Technical Skill Assessment

Revised 10/15

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Rate the skills below as follows: (1) Support (only execution) (2) Previous Experience (document preparation, execution) (3) Strong Experience (document preparation, execution, investigation) (4) Subject Matter Expert (SME) (document preparation, execution, investigation, revision, training, more than 5 years of experience in the area)

Mechanical Validation/Qualification/Verification/Commissioning
	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Validation Life Cycle Methodology	• Validation Life Cycle MethodologySupport	• Validation Life Cycle MethodologyPrevious Experience	• Validation Life Cycle MethodologyStrong Experience	• Validation Life Cycle MethodologySubject Matter Expert
• Develops and executes of Protocols	• Develops and executes of ProtocolsSupport	• Develops and executes of ProtocolsPrevious Experience	• Develops and executes of ProtocolsStrong Experience	• Develops and executes of ProtocolsSubject Matter Expert
• Validation Master Plan	• Validation Master PlanSupport	• Validation Master PlanPrevious Experience	• Validation Master PlanStrong Experience	• Validation Master PlanSubject Matter Expert
• Protocol Preparation	• Protocol PreparationSupport	• Protocol PreparationPrevious Experience	• Protocol PreparationStrong Experience	• Protocol PreparationSubject Matter Expert
• User/Functional Requirements	• User/Functional RequirementsSupport	• User/Functional RequirementsPrevious Experience	• User/Functional RequirementsStrong Experience	• User/Functional RequirementsSubject Matter Expert
• Design Qualification	• Design QualificationSupport	• Design QualificationPrevious Experience	• Design QualificationStrong Experience	• Design QualificationSubject Matter Expert
• Supplier Assessment	• Supplier AssessmentSupport	• Supplier AssessmentPrevious Experience	• Supplier AssessmentStrong Experience	• Supplier AssessmentSubject Matter Expert
• Change Request development	• Change Request developmentSupport	• Change Request developmentPrevious Experience	• Change Request developmentStrong Experience	• Change Request developmentSubject Matter Expert
• Installation Qualification/verification/commissioning	• Installation Qualification/verification/commissioning Support	• Installation Qualification/verification/commissioning Previous Experience	• Installation Qualification/verification/commissioning Strong Experience	• Installation Qualification/verification/commissioning Subject Matter Expert
• Operational Qualification/verification/commissioning	• Operational Qualification/verification/commissioningSupport	• Operational Qualification/verification/commissioningPrevious Experience	• Operational Qualification/verification/commissioningStrong Experience	• Operational Qualification/verification/commissioningSubject Matter Expert
• Performance Qualification	• Performance Qualification Support	• Performance Qualification Previous Experience	• Performance Qualification Strong Experience	• Performance Qualification Subject Matter Expert
• Factory Acceptance Test (FAT)	• Factory Acceptance Test (FAT)Support	• Factory Acceptance Test (FAT)Previous Experience	• Factory Acceptance Test (FAT)Strong Experience	• Factory Acceptance Test (FAT)Subject Matter Expert
• Site Acceptance Test (SAT)	• Site Acceptance Test (SAT) Support	• Site Acceptance Test (SAT) Previous Experience	• Site Acceptance Test (SAT) Strong Experience	• Site Acceptance Test (SAT) Subject Matter Expert
• Traceability Matrix (TM)	• Traceability Matrix (TM) Support	• Traceability Matrix (TM) Previous Experience	• Traceability Matrix (TM) Strong Experience	• Traceability Matrix (TM) Subject Matter Expert
• SOP’s preparation	• SOP’s preparationSupport	• SOP’s preparationPrevious Experience	• SOP’s preparationStrong Experience	• SOP’s preparationSubject Matter Expert
• Summary/Final Report	• Summary/Final ReportSupport	• Summary/Final ReportPrevious Experience	• Summary/Final ReportStrong Experience	• Summary/Final ReportSubject Matter Expert
• Risk Assessment	• Risk AssessmentSupport	• Risk AssessmentPrevious Experience	• Risk AssessmentStrong Experience	• Risk AssessmentSubject Matter Expert
• Commissioning	• Commissioning Support	• Commissioning Previous Experience	• Commissioning Strong Experience	• Commissioning Subject Matter Expert
• Decommissioning	• Decommissioning Support	• Decommissioning Previous Experience	• Decommissioning Strong Experience	• Decommissioning Subject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Experience	• Other:Subject Matter Expert

Facility/Utilities
Facility/Utilities	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Safety Data Sheets (SDS)	• Safety Data Sheets (SDS)Support	• Safety Data Sheets (SDS)Previous Experience	• Safety Data Sheets (SDS)Strong Experience	• Safety Data Sheets (SDS)Subject Matter Expert
• OSHA	• OSHASupport	• OSHAPrevious Experience	• OSHAStrong Experience	• OSHASubject Matter Expert
• P&ID	• P&IDSupport	• P&IDPrevious Experience	• P&IDStrong Experience	• P&IDSubject Matter Expert
• Pressure Vessels	• Pressure VesselsSupport	• Pressure VesselsPrevious Experience	• Pressure VesselsStrong Experience	• Pressure VesselsSubject Matter Expert
• Compressed Air Dryers	• Compressed Air DryersSupport	• Compressed Air DryersPrevious Experience	• Compressed Air DryersStrong Experience	• Compressed Air DryersSubject Matter Expert
• Coalescing Filters	• Coalescing FiltersSupport	• Coalescing FiltersPrevious Experience	• Coalescing FiltersStrong Experience	• Coalescing FiltersSubject Matter Expert
• Particle Filters	• Particle FiltersSupport	• Particle FiltersPrevious Experience	• Particle FiltersStrong Experience	• Particle FiltersSubject Matter Expert
• Microns / PPM	• Microns / PPMSupport	• Microns / PPMPrevious Experience	• Microns / PPMStrong Experience	• Microns / PPMSubject Matter Expert
• Nitrogen Systems Validation	• Nitrogen Systems ValidationSupport	• Nitrogen Systems ValidationPrevious Experience	• Nitrogen Systems ValidationStrong Experience	• Nitrogen Systems ValidationSubject Matter Expert
• Clean Steam Validation	• Clean Steam ValidationSupport	• Clean Steam ValidationPrevious Experience	• Clean Steam ValidationStrong Experience	• Clean Steam ValidationSubject Matter Expert
• Plant Steam Validation	• Plant Steam ValidationSupport	• Plant Steam ValidationPrevious Experience	• Plant Steam ValidationStrong Experience	• Plant Steam ValidationSubject Matter Expert
• Boilers	• BoilersSupport	• BoilersPrevious Experience	• BoilersStrong Experience	• BoilersSubject Matter Expert
• UPS Systems	• UPS SystemsSupport	• UPS SystemsPrevious Experience	• UPS SystemsStrong Experience	• UPS SystemsSubject Matter Expert
• Sampling Points/Sampling Frequency/Sampling Plan	• Sampling Points/Sampling Frequency/Sampling PlanSupport	• Sampling Points/Sampling Frequency/Sampling PlanPrevious Experience	• Sampling Points/Sampling Frequency/Sampling PlanStrong Experience	• Sampling Points/Sampling Frequency/Sampling PlanSubject Matter Expert
• GMP / Non-GMP Facility Qualification for: Manufacturing Rooms, Laboratories, Aseptic Areas, PI&D, Construction specifications of floors, walls ceiling and doors, Electrical/power specifications, illumination, drains, safety inspections, Environmental Monitoring, Microbiological Monitoring	• GMP / Non-GMP Facility Qualification for: Manufacturing Rooms, Laboratories, Aseptic Areas, PI&D, Construction specifications of floors, walls ceiling and doors, Electrical/power specifications, illumination, drains, safety inspections, Environmental Monitoring, Microbiological MonitoringSupport	• GMP / Non-GMP Facility Qualification for: Manufacturing Rooms, Laboratories, Aseptic Areas, PI&D, Construction specifications of floors, walls ceiling and doors, Electrical/power specifications, illumination, drains, safety inspections, Environmental Monitoring, Microbiological MonitoringPrevious Experience	• GMP / Non-GMP Facility Qualification for: Manufacturing Rooms, Laboratories, Aseptic Areas, PI&D, Construction specifications of floors, walls ceiling and doors, Electrical/power specifications, illumination, drains, safety inspections, Environmental Monitoring, Microbiological MonitoringStrong Experience	• GMP / Non-GMP Facility Qualification for: Manufacturing Rooms, Laboratories, Aseptic Areas, PI&D, Construction specifications of floors, walls ceiling and doors, Electrical/power specifications, illumination, drains, safety inspections, Environmental Monitoring, Microbiological MonitoringSubject Matter Expert
• Piping specifications, dead legs, use point stations, pumps, valves, rupture disks, hydrophobic filters, heat exchangers.	• Piping specifications, dead legs, use point stations, pumps, valves, rupture disks, hydrophobic filters, heat exchangers.Support	• Piping specifications, dead legs, use point stations, pumps, valves, rupture disks, hydrophobic filters, heat exchangers.Previous Experience	• Piping specifications, dead legs, use point stations, pumps, valves, rupture disks, hydrophobic filters, heat exchangers.Strong Experience	• Piping specifications, dead legs, use point stations, pumps, valves, rupture disks, hydrophobic filters, heat exchangers.Subject Matter Expert
• Flow meter test equipment	• Flow meter test equipmentSupport	• Flow meter test equipmentPrevious Experience	• Flow meter test equipmentStrong Experience	• Flow meter test equipmentSubject Matter Expert
• Pressure Gauges test equipment	• Pressure Gauges test equipmentSupport	• Pressure Gauges test equipmentPrevious Experience	• Pressure Gauges test equipmentStrong Experience	• Pressure Gauges test equipmentSubject Matter Expert
• HEPA Filters	• HEPA FiltersSupport	• HEPA FiltersPrevious Experience	• HEPA FiltersStrong Experience	• HEPA FiltersSubject Matter Expert
• Environmental Areas certifications (Filter Integrity test, non-viable particle monitoring, air-flow pattern, room air changes, room’s differential pressure, Humidity and Temperature)	• Environmental Areas certifications (Filter Integrity test, non-viable particle monitoring, air-flow pattern, room air changes, room’s differential pressure, Humidity and Temperature)Support	• Environmental Areas certifications (Filter Integrity test, non-viable particle monitoring, air-flow pattern, room air changes, room’s differential pressure, Humidity and Temperature)Previous Experience	• Environmental Areas certifications (Filter Integrity test, non-viable particle monitoring, air-flow pattern, room air changes, room’s differential pressure, Humidity and Temperature)Strong Experience	• Environmental Areas certifications (Filter Integrity test, non-viable particle monitoring, air-flow pattern, room air changes, room’s differential pressure, Humidity and Temperature)Subject Matter Expert
• Storm Sewer System	• Storm Sewer SystemSupport	• Storm Sewer SystemPrevious Experience	• Storm Sewer SystemStrong Experience	• Storm Sewer SystemSubject Matter Expert
• Temperature and relative Humidity Mapping (Warehouse)	• Temperature and relative Humidity Mapping (Warehouse)Support	• Temperature and relative Humidity Mapping (Warehouse)Previous Experience	• Temperature and relative Humidity Mapping (Warehouse)Strong Experience	• Temperature and relative Humidity Mapping (Warehouse)Subject Matter Expert
• Temperature and relative Humidity Mapping (Manufacturing and Packaging Areas)	• Temperature and relative Humidity Mapping (Manufacturing and Packaging Areas)Support	• Temperature and relative Humidity Mapping (Manufacturing and Packaging Areas)Previous Experience	• Temperature and relative Humidity Mapping (Manufacturing and Packaging Areas)Strong Experience	• Temperature and relative Humidity Mapping (Manufacturing and Packaging Areas)Subject Matter Expert
• Building Management System (BMS/QBMS/UMS)	• Building Management System (BMS/QBMS/UMS) Support	• Building Management System (BMS/QBMS/UMS) Previous Experience	• Building Management System (BMS/QBMS/UMS) Strong Experience	• Building Management System (BMS/QBMS/UMS) Subject Matter Expert
• Building Automation System (BAS / QBAS)	• Building Automation System (BAS / QBAS)Support	• Building Automation System (BAS / QBAS)Previous Experience	• Building Automation System (BAS / QBAS)Strong Experience	• Building Automation System (BAS / QBAS)Subject Matter Expert
• Process Automation System (PAS)	• Process Automation System (PAS)Support	• Process Automation System (PAS)Previous Experience	• Process Automation System (PAS)Strong Experience	• Process Automation System (PAS)Subject Matter Expert
• DPT / TT	• DPT / TTSupport	• DPT / TTPrevious Experience	• DPT / TTStrong Experience	• DPT / TTSubject Matter Expert
• Smoke Test Profiles	• Smoke Test ProfilesSupport	• Smoke Test ProfilesPrevious Experience	• Smoke Test ProfilesStrong Experience	• Smoke Test ProfilesSubject Matter Expert
• AHU (Air Handling Units) Validation	• AHU (Air Handling Units) ValidationSupport	• AHU (Air Handling Units) ValidationPrevious Experience	• AHU (Air Handling Units) ValidationStrong Experience	• AHU (Air Handling Units) ValidationSubject Matter Expert
• HVAC Balance Reports	• HVAC Balance ReportsSupport	• HVAC Balance ReportsPrevious Experience	• HVAC Balance ReportsStrong Experience	• HVAC Balance ReportsSubject Matter Expert
• Heating/Cooling Coils	• Heating/Cooling CoilsSupport	• Heating/Cooling CoilsPrevious Experience	• Heating/Cooling CoilsStrong Experience	• Heating/Cooling CoilsSubject Matter Expert
• Make-up Units	• Make-up UnitsSupport	• Make-up UnitsPrevious Experience	• Make-up UnitsStrong Experience	• Make-up UnitsSubject Matter Expert
• Ducts construction/ modification (including supplies and returns)	• Ducts construction/ modification (including supplies and returns)Support	• Ducts construction/ modification (including supplies and returns)Previous Experience	• Ducts construction/ modification (including supplies and returns)Strong Experience	• Ducts construction/ modification (including supplies and returns)Subject Matter Expert
• Chillers	• ChillersSupport	• ChillersPrevious Experience	• ChillersStrong Experience	• ChillersSubject Matter Expert
• Cooling Tower	• Cooling TowerSupport	• Cooling TowerPrevious Experience	• Cooling TowerStrong Experience	• Cooling TowerSubject Matter Expert
• Pumps	• PumpsSupport	• PumpsPrevious Experience	• PumpsStrong Experience	• PumpsSubject Matter Expert
• Reheat Water Plate Heat Exchangers	• Reheat Water Plate Heat ExchangersSupport	• Reheat Water Plate Heat ExchangersPrevious Experience	• Reheat Water Plate Heat ExchangersStrong Experience	• Reheat Water Plate Heat ExchangersSubject Matter Expert
• WFI Distribution System and Loop Validation	• WFI Distribution System and Loop ValidationSupport	• WFI Distribution System and Loop ValidationPrevious Experience	• WFI Distribution System and Loop ValidationStrong Experience	• WFI Distribution System and Loop ValidationSubject Matter Expert
• USP Water Distribution System and Loop Validation	• USP Water Distribution System and Loop ValidationSupport	• USP Water Distribution System and Loop ValidationPrevious Experience	• USP Water Distribution System and Loop ValidationStrong Experience	• USP Water Distribution System and Loop ValidationSubject Matter Expert
• Potable Water Distribution System and Loop Validation	• Potable Water Distribution System and Loop ValidationSupport	• Potable Water Distribution System and Loop ValidationPrevious Experience	• Potable Water Distribution System and Loop ValidationStrong Experience	• Potable Water Distribution System and Loop ValidationSubject Matter Expert
• Purified Water Distribution System and Loop Validation	• Purified Water Distribution System and Loop ValidationSupport	• Purified Water Distribution System and Loop ValidationPrevious Experience	• Purified Water Distribution System and Loop ValidationStrong Experience	• Purified Water Distribution System and Loop ValidationSubject Matter Expert
• DI Water Loop Validation	• DI Water Loop ValidationSupport	• DI Water Loop ValidationPrevious Experience	• DI Water Loop ValidationStrong Experience	• DI Water Loop ValidationSubject Matter Expert
• ROW Loop Validation	• ROW Loop ValidationSupport	• ROW Loop ValidationPrevious Experience	• ROW Loop ValidationStrong Experience	• ROW Loop ValidationSubject Matter Expert
• Pre-treatment Loop (RO units, Ozone systems, UV Light, Multimedia filters, Carbon Filters)	• Pre-treatment Loop (RO units, Ozone systems, UV Light, Multimedia filters, Carbon Filters)Support	• Pre-treatment Loop (RO units, Ozone systems, UV Light, Multimedia filters, Carbon Filters)Previous Experience	• Pre-treatment Loop (RO units, Ozone systems, UV Light, Multimedia filters, Carbon Filters)Strong Experience	• Pre-treatment Loop (RO units, Ozone systems, UV Light, Multimedia filters, Carbon Filters)Subject Matter Expert
• CDI, Chlorine Injection Unit, Metabisulfite Injection Units, Tanks	• CDI, Chlorine Injection Unit, Metabisulfite Injection Units, TanksSupport	• CDI, Chlorine Injection Unit, Metabisulfite Injection Units, TanksPrevious Experience	• CDI, Chlorine Injection Unit, Metabisulfite Injection Units, TanksStrong Experience	• CDI, Chlorine Injection Unit, Metabisulfite Injection Units, TanksSubject Matter Expert
• Compressed Air Distribution System	• Compressed Air Distribution SystemSupport	• Compressed Air Distribution SystemPrevious Experience	• Compressed Air Distribution SystemStrong Experience	• Compressed Air Distribution SystemSubject Matter Expert
• Compressed Air Dryers	• Compressed Air DryersSupport	• Compressed Air DryersPrevious Experience	• Compressed Air DryersStrong Experience	• Compressed Air DryersSubject Matter Expert
• CFM’s	• CFM’sSupport	• CFM’sPrevious Experience	• CFM’sStrong Experience	• CFM’sSubject Matter Expert
• Dew Point	• Dew PointSupport	• Dew PointPrevious Experience	• Dew PointStrong Experience	• Dew PointSubject Matter Expert
• Hygrometers	• HygrometersSupport	• HygrometersPrevious Experience	• HygrometersStrong Experience	• HygrometersSubject Matter Expert
• Automatic Ball Valves	• Automatic Ball ValvesSupport	• Automatic Ball ValvesPrevious Experience	• Automatic Ball ValvesStrong Experience	• Automatic Ball ValvesSubject Matter Expert
• Argon Systems Validation	• Argon Systems ValidationSupport	• Argon Systems ValidationPrevious Experience	• Argon Systems ValidationStrong Experience	• Argon Systems ValidationSubject Matter Expert
• Other	• OtherSupport	• OtherPrevious Experience	• OtherStrong Experience	• OtherSubject Matter Expert

Investigations/QA Services
Investigations/QA Services	Support	Previous Experience	Strong Experience	Subject Matter Expert
• CAPA	• CAPASupport	• CAPAPrevious Experience	• CAPAStrong Experience	• CAPASubject Matter Expert
• Effectiveness Checks	• Effectiveness ChecksSupport	• Effectiveness ChecksPrevious Experience	• Effectiveness ChecksStrong Experience	• Effectiveness ChecksSubject Matter Expert
• Lab Investigations	• Lab InvestigationsSupport	• Lab InvestigationsPrevious Experience	• Lab InvestigationsStrong Experience	• Lab InvestigationsSubject Matter Expert
• Out of Specs, Non Conformance	• Out of Specs, Non ConformanceSupport	• Out of Specs, Non ConformancePrevious Experience	• Out of Specs, Non ConformanceStrong Experience	• Out of Specs, Non ConformanceSubject Matter Expert
• Consent Decree	• Consent DecreeSupport	• Consent DecreePrevious Experience	• Consent DecreeStrong Experience	• Consent DecreeSubject Matter Expert
• Audits	• AuditsSupport	• AuditsPrevious Experience	• AuditsStrong Experience	• AuditsSubject Matter Expert
• Inspection Readiness	• Inspection ReadinessSupport	• Inspection ReadinessPrevious Experience	• Inspection ReadinessStrong Experience	• Inspection ReadinessSubject Matter Expert
• Experience with Regulatory Agencies: FDA (CBER/CDER), EMEA, MHRA, ANVISA, etc.	• Experience with Regulatory Agencies: FDA (CBER/CDER), EMEA, MHRA, ANVISA, etc.Support	• Experience with Regulatory Agencies: FDA (CBER/CDER), EMEA, MHRA, ANVISA, etc.Previous Experience	• Experience with Regulatory Agencies: FDA (CBER/CDER), EMEA, MHRA, ANVISA, etc.Strong Experience	• Experience with Regulatory Agencies: FDA (CBER/CDER), EMEA, MHRA, ANVISA, etc.Subject Matter Expert
• Commitments	• CommitmentsSupport	• CommitmentsPrevious Experience	• CommitmentsStrong Experience	• CommitmentsSubject Matter Expert
• Complaints	• ComplaintsSupport	• ComplaintsPrevious Experience	• ComplaintsStrong Experience	• ComplaintsSubject Matter Expert
• Stability Studies	• Stability StudiesSupport	• Stability StudiesPrevious Experience	• Stability StudiesStrong Experience	• Stability StudiesSubject Matter Expert
• Batch Record Review	• Batch Record ReviewSupport	• Batch Record ReviewPrevious Experience	• Batch Record ReviewStrong Experience	• Batch Record ReviewSubject Matter Expert
• Product Release	• Product ReleaseSupport	• Product ReleasePrevious Experience	• Product ReleaseStrong Experience	• Product ReleaseSubject Matter Expert
• Participate with cross functional team in decision making for immediate actions during incidents	• Participate with cross functional team in decision making for immediate actions during incidentsSupport	• Participate with cross functional team in decision making for immediate actions during incidentsPrevious Experience	• Participate with cross functional team in decision making for immediate actions during incidentsStrong Experience	• Participate with cross functional team in decision making for immediate actions during incidentsSubject Matter Expert
• Events/Deviations	• Events/DeviationsSupport	• Events/DeviationsPrevious Experience	• Events/DeviationsStrong Experience	• Events/DeviationsSubject Matter Expert
• FMEA	• FMEASupport	• FMEAPrevious Experience	• FMEAStrong Experience	• FMEASubject Matter Expert
• Risk Assessments	• Risk AssessmentsSupport	• Risk AssessmentsPrevious Experience	• Risk AssessmentsStrong Experience	• Risk AssessmentsSubject Matter Expert
• Protocols reviewer/approver	• Protocols reviewer/approverSupport	• Protocols reviewer/approverPrevious Experience	• Protocols reviewer/approverStrong Experience	• Protocols reviewer/approverSubject Matter Expert
• Root Cause Analysis	• Root Cause AnalysisSupport	• Root Cause AnalysisPrevious Experience	• Root Cause AnalysisStrong Experience	• Root Cause AnalysisSubject Matter Expert
• Investigation Metrics	• Investigation Metrics Support	• Investigation Metrics Previous Experience	• Investigation Metrics Strong Experience	• Investigation Metrics Subject Matter Expert
• Related software	• Related softwareSupport	• Related softwarePrevious Experience	• Related softwareStrong Experience	• Related softwareSubject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Experience	• Other:Subject Matter Expert

Software/ Applications/Systems
Software/ Applications/Systems	Support	Previous Experience	Strong Experience	Subject Matter Expert
• MRPs (i.e. SAP, JD Edwards, BPCS, etc.)	• MRPs (i.e. SAP, JD Edwards, BPCS, etc.)Support	• MRPs (i.e. SAP, JD Edwards, BPCS, etc.)Previous Experience	• MRPs (i.e. SAP, JD Edwards, BPCS, etc.)Strong Experience	• MRPs (i.e. SAP, JD Edwards, BPCS, etc.)Subject Matter Expert
• Maximo (PM/Calibration software (i.e. Maximo, gagetrack, etc.))	• Maximo (PM/Calibration software (i.e. Maximo, gagetrack, etc.))Support	• Maximo (PM/Calibration software (i.e. Maximo, gagetrack, etc.))Previous Experience	• Maximo (PM/Calibration software (i.e. Maximo, gagetrack, etc.))Strong Experience	• Maximo (PM/Calibration software (i.e. Maximo, gagetrack, etc.))Subject Matter Expert
• Compliance Wire (Training Software (Compliance wire, etc.))	• Compliance Wire (Training Software (Compliance wire, etc.))Support	• Compliance Wire (Training Software (Compliance wire, etc.))Previous Experience	• Compliance Wire (Training Software (Compliance wire, etc.))Strong Experience	• Compliance Wire (Training Software (Compliance wire, etc.))Subject Matter Expert
• Documenttum based applications (AGILE, e-Doc, OneSource, cPDM, Documentum, etc.)	• Documenttum based applications (AGILE, e-Doc, OneSource, cPDM, Documentum, etc.)Support	• Documenttum based applications (AGILE, e-Doc, OneSource, cPDM, Documentum, etc.)Previous Experience	• Documenttum based applications (AGILE, e-Doc, OneSource, cPDM, Documentum, etc.)Strong Experience	• Documenttum based applications (AGILE, e-Doc, OneSource, cPDM, Documentum, etc.)Subject Matter Expert
• Trackwise (Iinvestigations, CAPA Software (Trackwise))	• Trackwise (Iinvestigations, CAPA Software (Trackwise))Support	• Trackwise (Iinvestigations, CAPA Software (Trackwise))Previous Experience	• Trackwise (Iinvestigations, CAPA Software (Trackwise))Strong Experience	• Trackwise (Iinvestigations, CAPA Software (Trackwise))Subject Matter Expert
• Electronic Batch Record/Manufacturing Execution Systems MES (CAMSTAR, EMERSON DELTA V)	• Electronic Batch Record/Manufacturing Execution Systems MES (CAMSTAR, EMERSON DELTA V)Support	• Electronic Batch Record/Manufacturing Execution Systems MES (CAMSTAR, EMERSON DELTA V)Previous Experience	• Electronic Batch Record/Manufacturing Execution Systems MES (CAMSTAR, EMERSON DELTA V)Strong Experience	• Electronic Batch Record/Manufacturing Execution Systems MES (CAMSTAR, EMERSON DELTA V)Subject Matter Expert
• Laboratory software (LabWare, LIMS)	• Laboratory software (LabWare, LIMS)Support	• Laboratory software (LabWare, LIMS)Previous Experience	• Laboratory software (LabWare, LIMS)Strong Experience	• Laboratory software (LabWare, LIMS)Subject Matter Expert
• SCADA Systems	• SCADA SystemsSupport	• SCADA SystemsPrevious Experience	• SCADA SystemsStrong Experience	• SCADA SystemsSubject Matter Expert
• PLC’s/Ladder Logic Programming	• PLC’s/Ladder Logic ProgrammingSupport	• PLC’s/Ladder Logic ProgrammingPrevious Experience	• PLC’s/Ladder Logic ProgrammingStrong Experience	• PLC’s/Ladder Logic ProgrammingSubject Matter Expert
• Honeywell’s Applications, Enterprise Building Integrator (EBi), Plantscape, Experion, etc.	• Honeywell’s Applications, Enterprise Building Integrator (EBi), Plantscape, Experion, etc.Support	• Honeywell’s Applications, Enterprise Building Integrator (EBi), Plantscape, Experion, etc.Previous Experience	• Honeywell’s Applications, Enterprise Building Integrator (EBi), Plantscape, Experion, etc.Strong Experience	• Honeywell’s Applications, Enterprise Building Integrator (EBi), Plantscape, Experion, etc.Subject Matter Expert
• Scientek Stability System (Scientek)	• Scientek Stability System (Scientek)Support	• Scientek Stability System (Scientek)Previous Experience	• Scientek Stability System (Scientek)Strong Experience	• Scientek Stability System (Scientek)Subject Matter Expert
• Systems Investigations Owner	• Systems Investigations OwnerSupport	• Systems Investigations OwnerPrevious Experience	• Systems Investigations OwnerStrong Experience	• Systems Investigations OwnerSubject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Experience	• Other:Subject Matter Expert

Cleaning Validation
Cleaning Validation	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Acceptance Limit Calculations/Toxicity Criteria (10 ppm Criteria, Dose Criterion, MACO – Maximum Allowable Carryover)	• Acceptance Limit Calculations/Toxicity Criteria (10 ppm Criteria, Dose Criterion, MACO – Maximum Allowable Carryover)Support	• Acceptance Limit Calculations/Toxicity Criteria (10 ppm Criteria, Dose Criterion, MACO – Maximum Allowable Carryover)Previous Experience	• Acceptance Limit Calculations/Toxicity Criteria (10 ppm Criteria, Dose Criterion, MACO – Maximum Allowable Carryover)Strong Experience	• Acceptance Limit Calculations/Toxicity Criteria (10 ppm Criteria, Dose Criterion, MACO – Maximum Allowable Carryover)Subject Matter Expert
• Cleaning Protocol preparation, execution and final report	• Cleaning Protocol preparation, execution and final reportSupport	• Cleaning Protocol preparation, execution and final reportPrevious Experience	• Cleaning Protocol preparation, execution and final reportStrong Experience	• Cleaning Protocol preparation, execution and final reportSubject Matter Expert
• Grouping matrixes (per equipment type, per product, etc.)	• Grouping matrixes (per equipment type, per product, etc.)Support	• Grouping matrixes (per equipment type, per product, etc.)Previous Experience	• Grouping matrixes (per equipment type, per product, etc.)Strong Experience	• Grouping matrixes (per equipment type, per product, etc.)Subject Matter Expert
• Equipment Train Area (surface contact, group of materials)	• Equipment Train Area (surface contact, group of materials)Support	• Equipment Train Area (surface contact, group of materials)Previous Experience	• Equipment Train Area (surface contact, group of materials)Strong Experience	• Equipment Train Area (surface contact, group of materials)Subject Matter Expert
• CIP/COP	• CIP/COPSupport	• CIP/COPPrevious Experience	• CIP/COPStrong Experience	• CIP/COPSubject Matter Expert
• Manual cleaning	• Manual cleaningSupport	• Manual cleaningPrevious Experience	• Manual cleaningStrong Experience	• Manual cleaningSubject Matter Expert
• Identification of Cleaning parameters (Water Quality, pressure/temperature parameters, rinsing times)	• Identification of Cleaning parameters (Water Quality, pressure/temperature parameters, rinsing times)Support	• Identification of Cleaning parameters (Water Quality, pressure/temperature parameters, rinsing times)Previous Experience	• Identification of Cleaning parameters (Water Quality, pressure/temperature parameters, rinsing times)Strong Experience	• Identification of Cleaning parameters (Water Quality, pressure/temperature parameters, rinsing times)Subject Matter Expert
• Analytical Methods (HPLC, UV, TOC, Conductivity, pH)	• Analytical Methods (HPLC, UV, TOC, Conductivity, pH)Support	• Analytical Methods (HPLC, UV, TOC, Conductivity, pH)Previous Experience	• Analytical Methods (HPLC, UV, TOC, Conductivity, pH)Strong Experience	• Analytical Methods (HPLC, UV, TOC, Conductivity, pH)Subject Matter Expert
• Recovery factors	• Recovery factorsSupport	• Recovery factorsPrevious Experience	• Recovery factorsStrong Experience	• Recovery factorsSubject Matter Expert
• Swab Samples	• Swab SamplesSupport	• Swab SamplesPrevious Experience	• Swab SamplesStrong Experience	• Swab SamplesSubject Matter Expert
• Rinse Samples	• Rinse SamplesSupport	• Rinse SamplesPrevious Experience	• Rinse SamplesStrong Experience	• Rinse SamplesSubject Matter Expert
• Immersion Samples	• Immersion SamplesSupport	• Immersion SamplesPrevious Experience	• Immersion SamplesStrong Experience	• Immersion SamplesSubject Matter Expert
• Holding Times (Cleaned, Dirty Equipment, between lots, etc)	• Holding Times (Cleaned, Dirty Equipment, between lots, etc)Support	• Holding Times (Cleaned, Dirty Equipment, between lots, etc)Previous Experience	• Holding Times (Cleaned, Dirty Equipment, between lots, etc)Strong Experience	• Holding Times (Cleaned, Dirty Equipment, between lots, etc)Subject Matter Expert
• Cleaning Agents	• Cleaning AgentsSupport	• Cleaning AgentsPrevious Experience	• Cleaning AgentsStrong Experience	• Cleaning AgentsSubject Matter Expert
• Solubility Concepts	• Solubility ConceptsSupport	• Solubility ConceptsPrevious Experience	• Solubility ConceptsStrong Experience	• Solubility ConceptsSubject Matter Expert
• Hard to clean areas	• Hard to clean areasSupport	• Hard to clean areasPrevious Experience	• Hard to clean areasStrong Experience	• Hard to clean areasSubject Matter Expert
• Microbiological Samples	• Microbiological SamplesSupport	• Microbiological SamplesPrevious Experience	• Microbiological SamplesStrong Experience	• Microbiological SamplesSubject Matter Expert
• Analytical Samples	• Analytical SamplesSupport	• Analytical SamplesPrevious Experience	• Analytical SamplesStrong Experience	• Analytical SamplesSubject Matter Expert
• Other	• OtherSupport	• OtherPrevious Experience	• OtherStrong Experience	• OtherSubject Matter Expert

Laboratory Instruments with corresponding applications
	Support	Previous Experience	Strong Experience	Subject Matter Expert
• FTIR	• FTIRSupport	• FTIRPrevious Experience	• FTIRStrong Experience	• FTIRSubject Matter Expert
• NIR	• NIRSupport	• NIRPrevious Experience	• NIRStrong Experience	• NIRSubject Matter Expert
• UV	• UVSupport	• UVPrevious Experience	• UVStrong Experience	• UVSubject Matter Expert
• HPLC	• HPLCSupport	• HPLCPrevious Experience	• HPLCStrong Experience	• HPLCSubject Matter Expert
• GC	• GCSupport	• GCPrevious Experience	• GCStrong Experience	• GCSubject Matter Expert
• Titroprocessor	• TitroprocessorSupport	• TitroprocessorPrevious Experience	• TitroprocessorStrong Experience	• TitroprocessorSubject Matter Expert
• TOC Analyzer	• TOC AnalyzerSupport	• TOC AnalyzerPrevious Experience	• TOC AnalyzerStrong Experience	• TOC AnalyzerSubject Matter Expert
• Dissolutions	• DissolutionsSupport	• DissolutionsPrevious Experience	• DissolutionsStrong Experience	• DissolutionsSubject Matter Expert
• Ion Chromatography	• Ion Chromatography Support	• Ion Chromatography Previous Experience	• Ion Chromatography Strong Experience	• Ion Chromatography Subject Matter Expert
• Raman	• RamanSupport	• RamanPrevious Experience	• RamanStrong Experience	• RamanSubject Matter Expert
• Sampling and analyzes Purified Water Points of Use	• Sampling and analyzes Purified Water Points of UseSupport	• Sampling and analyzes Purified Water Points of UsePrevious Experience	• Sampling and analyzes Purified Water Points of UseStrong Experience	• Sampling and analyzes Purified Water Points of UseSubject Matter Expert
• ChemStation Application	• ChemStation ApplicationSupport	• ChemStation ApplicationPrevious Experience	• ChemStation ApplicationStrong Experience	• ChemStation ApplicationSubject Matter Expert
• Empower Data Acquisition and Infrastructure	• Empower Data Acquisition and InfrastructureSupport	• Empower Data Acquisition and InfrastructurePrevious Experience	• Empower Data Acquisition and InfrastructureStrong Experience	• Empower Data Acquisition and InfrastructureSubject Matter Expert
• LIMS Sample Manager	• LIMS Sample ManagerSupport	• LIMS Sample ManagerPrevious Experience	• LIMS Sample ManagerStrong Experience	• LIMS Sample ManagerSubject Matter Expert
• QLIMS	• QLIMSSupport	• QLIMSPrevious Experience	• QLIMSStrong Experience	• QLIMSSubject Matter Expert
• SMARTLIMS	• SMARTLIMSSupport	• SMARTLIMSPrevious Experience	• SMARTLIMSStrong Experience	• SMARTLIMSSubject Matter Expert
• LIMS LABWARE (GLIMS)	• LIMS LABWARE (GLIMS)Support	• LIMS LABWARE (GLIMS)Previous Experience	• LIMS LABWARE (GLIMS)Strong Experience	• LIMS LABWARE (GLIMS)Subject Matter Expert
• Incoming Laboratory	• Incoming LaboratorySupport	• Incoming LaboratoryPrevious Experience	• Incoming LaboratoryStrong Experience	• Incoming LaboratorySubject Matter Expert
• Raw Material Laboratory	• Raw Material LaboratorySupport	• Raw Material LaboratoryPrevious Experience	• Raw Material LaboratoryStrong Experience	• Raw Material LaboratorySubject Matter Expert
• Finish Product Laboratory	• Finish Product LaboratorySupport	• Finish Product LaboratoryPrevious Experience	• Finish Product LaboratoryStrong Experience	• Finish Product LaboratorySubject Matter Expert
• Microbiology Laboratory	• Microbiology LaboratorySupport	• Microbiology LaboratoryPrevious Experience	• Microbiology LaboratoryStrong Experience	• Microbiology LaboratorySubject Matter Expert
• Stability Studies	• Stability StudiesSupport	• Stability StudiesPrevious Experience	• Stability StudiesStrong Experience	• Stability StudiesSubject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Experience	• Other:Subject Matter Expert

Biotechnology Industry
Biotechnology Industry	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Fermentors	• FermentorsSupport	• FermentorsPrevious Experience	• FermentorsStrong Experience	• FermentorsSubject Matter Expert
• Holding Tanks	• Holding Tanks Support	• Holding Tanks Previous Experience	• Holding Tanks Strong Experience	• Holding Tanks Subject Matter Expert
• Crystallizers	• CrystallizersSupport	• CrystallizersPrevious Experience	• CrystallizersStrong Experience	• CrystallizersSubject Matter Expert
• TFF	• TFFSupport	• TFFPrevious Experience	• TFFStrong Experience	• TFFSubject Matter Expert
• Filtration systems	• Filtration systemsSupport	• Filtration systemsPrevious Experience	• Filtration systemsStrong Experience	• Filtration systemsSubject Matter Expert
• Chromatographic Columns	• Chromatographic ColumnsSupport	• Chromatographic ColumnsPrevious Experience	• Chromatographic ColumnsStrong Experience	• Chromatographic ColumnsSubject Matter Expert
• Purification Concepts	• Purification ConceptsSupport	• Purification ConceptsPrevious Experience	• Purification ConceptsStrong Experience	• Purification ConceptsSubject Matter Expert
• Reactors	• ReactorsSupport	• ReactorsPrevious Experience	• ReactorsStrong Experience	• ReactorsSubject Matter Expert
• Diaphragm Pumps	• Diaphragm PumpsSupport	• Diaphragm PumpsPrevious Experience	• Diaphragm PumpsStrong Experience	• Diaphragm PumpsSubject Matter Expert
• Centrifugal Pumps	• Centrifugal PumpsSupport	• Centrifugal PumpsPrevious Experience	• Centrifugal PumpsStrong Experience	• Centrifugal PumpsSubject Matter Expert
• Agitators	• AgitatorsSupport	• AgitatorsPrevious Experience	• AgitatorsStrong Experience	• AgitatorsSubject Matter Expert
• Incubators tests	• Incubators testsSupport	• Incubators testsPrevious Experience	• Incubators testsStrong Experience	• Incubators testsSubject Matter Expert
• Other	• OtherSupport	• OtherPrevious Experience	• OtherStrong Experience	• OtherSubject Matter Expert

Oral Solid Dosage
Oral Solid Dosage	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Granulators/Blender (Wet or Dry)	• Granulators/Blender (Wet or Dry)Support	• Granulators/Blender (Wet or Dry)Previous Experience	• Granulators/Blender (Wet or Dry)Strong Experience	• Granulators/Blender (Wet or Dry)Subject Matter Expert
• Dryers (Aeromatic, oven, Fluid Bed)	• Dryers (Aeromatic, oven, Fluid Bed)Support	• Dryers (Aeromatic, oven, Fluid Bed)Previous Experience	• Dryers (Aeromatic, oven, Fluid Bed)Strong Experience	• Dryers (Aeromatic, oven, Fluid Bed)Subject Matter Expert
• Compressing Machines (Fette, Korsh, Manesty, etc.)	• Compressing Machines (Fette, Korsh, Manesty, etc.)Support	• Compressing Machines (Fette, Korsh, Manesty, etc.)Previous Experience	• Compressing Machines (Fette, Korsh, Manesty, etc.)Strong Experience	• Compressing Machines (Fette, Korsh, Manesty, etc.)Subject Matter Expert
• Tablet Tester (Dr. Schleuniger, AT-4)	• Tablet Tester (Dr. Schleuniger, AT-4)Support	• Tablet Tester (Dr. Schleuniger, AT-4)Previous Experience	• Tablet Tester (Dr. Schleuniger, AT-4)Strong Experience	• Tablet Tester (Dr. Schleuniger, AT-4)Subject Matter Expert
• Dust Collector System	• Dust Collector SystemSupport	• Dust Collector SystemPrevious Experience	• Dust Collector SystemStrong Experience	• Dust Collector SystemSubject Matter Expert
• Laser Drill Machines	• Laser Drill MachinesSupport	• Laser Drill MachinesPrevious Experience	• Laser Drill MachinesStrong Experience	• Laser Drill MachinesSubject Matter Expert
• Metal Detection	• Metal DetectionSupport	• Metal DetectionPrevious Experience	• Metal DetectionStrong Experience	• Metal DetectionSubject Matter Expert
• Sorting	• SortingSupport	• SortingPrevious Experience	• SortingStrong Experience	• SortingSubject Matter Expert
• Tablet Dedusters	• Tablet DedustersSupport	• Tablet DedustersPrevious Experience	• Tablet DedustersStrong Experience	• Tablet DedustersSubject Matter Expert
• Branding Equipment	• Branding EquipmentSupport	• Branding EquipmentPrevious Experience	• Branding EquipmentStrong Experience	• Branding EquipmentSubject Matter Expert
• Coating (film coating/sugar coating)	• Coating (film coating/sugar coating)Support	• Coating (film coating/sugar coating)Previous Experience	• Coating (film coating/sugar coating)Strong Experience	• Coating (film coating/sugar coating)Subject Matter Expert
• Continuous Tablet Coater (CTC)	• Continuous Tablet Coater (CTC)Support	• Continuous Tablet Coater (CTC)Previous Experience	• Continuous Tablet Coater (CTC)Strong Experience	• Continuous Tablet Coater (CTC)Subject Matter Expert
• Solution Preparation Tanks	• Solution Preparation TanksSupport	• Solution Preparation TanksPrevious Experience	• Solution Preparation TanksStrong Experience	• Solution Preparation TanksSubject Matter Expert
• Sievers/Milling Equipment (Oscillator, Cone mill, Hammer Mill)	• Sievers/Milling Equipment (Oscillator, Cone mill, Hammer Mill)Support	• Sievers/Milling Equipment (Oscillator, Cone mill, Hammer Mill)Previous Experience	• Sievers/Milling Equipment (Oscillator, Cone mill, Hammer Mill)Strong Experience	• Sievers/Milling Equipment (Oscillator, Cone mill, Hammer Mill)Subject Matter Expert
• Drum Lifter Inverter/Vacuum Loading Systems	• Drum Lifter Inverter/Vacuum Loading SystemsSupport	• Drum Lifter Inverter/Vacuum Loading SystemsPrevious Experience	• Drum Lifter Inverter/Vacuum Loading SystemsStrong Experience	• Drum Lifter Inverter/Vacuum Loading SystemsSubject Matter Expert
• In-process Testing Instruments	• In-process Testing InstrumentsSupport	• In-process Testing InstrumentsPrevious Experience	• In-process Testing InstrumentsStrong Experience	• In-process Testing InstrumentsSubject Matter Expert
• PAT	• PATSupport	• PATPrevious Experience	• PATStrong Experience	• PATSubject Matter Expert
• Encapsulators	• EncapsulatorsSupport	• EncapsulatorsPrevious Experience	• EncapsulatorsStrong Experience	• EncapsulatorsSubject Matter Expert
• Printing Machines	• Printing MachinesSupport	• Printing MachinesPrevious Experience	• Printing MachinesStrong Experience	• Printing MachinesSubject Matter Expert
• Equipment Washing ( Clean-in-Place (CIP) system)	• Equipment Washing ( Clean-in-Place (CIP) system)Support	• Equipment Washing ( Clean-in-Place (CIP) system)Previous Experience	• Equipment Washing ( Clean-in-Place (CIP) system)Strong Experience	• Equipment Washing ( Clean-in-Place (CIP) system)Subject Matter Expert
• Equipment sterilization (Sterilize-in-Place (SIP) system)	• Equipment sterilization (Sterilize-in-Place (SIP) system)Support	• Equipment sterilization (Sterilize-in-Place (SIP) system)Previous Experience	• Equipment sterilization (Sterilize-in-Place (SIP) system)Strong Experience	• Equipment sterilization (Sterilize-in-Place (SIP) system)Subject Matter Expert
• Autoclave (non-product)	• Autoclave (non-product)Support	• Autoclave (non-product)Previous Experience	• Autoclave (non-product)Strong Experience	• Autoclave (non-product)Subject Matter Expert
• Kaye Validator	• Kaye ValidatorSupport	• Kaye ValidatorPrevious Experience	• Kaye ValidatorStrong Experience	• Kaye ValidatorSubject Matter Expert
• Data Loggers	• Data LoggersSupport	• Data LoggersPrevious Experience	• Data LoggersStrong Experience	• Data LoggersSubject Matter Expert
• Warm Rooms	• Warm RoomsSupport	• Warm RoomsPrevious Experience	• Warm RoomsStrong Experience	• Warm RoomsSubject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Experience	• Other:Subject Matter Expert

Computer Validation:
Computer Validation:	Support	Previous Experience	Strong Exdperience	Subject Matter Expert
• System Development Life Cycle Methodology	• System Development Life Cycle MethodologySupport	• System Development Life Cycle MethodologyPrevious Experience	• System Development Life Cycle MethodologyStrong Exdperience	• System Development Life Cycle MethodologySubject Matter Expert
• 21 CFR Part 11	• 21 CFR Part 11Support	• 21 CFR Part 11Previous Experience	• 21 CFR Part 11Strong Exdperience	• 21 CFR Part 11Subject Matter Expert
• Develops and executes of Protocols	• Develops and executes of ProtocolsSupport	• Develops and executes of ProtocolsPrevious Experience	• Develops and executes of ProtocolsStrong Exdperience	• Develops and executes of ProtocolsSubject Matter Expert
• GAMP’s	• GAMP’sSupport	• GAMP’sPrevious Experience	• GAMP’sStrong Exdperience	• GAMP’sSubject Matter Expert
• GAMP 5	• GAMP 5Support	• GAMP 5Previous Experience	• GAMP 5Strong Exdperience	• GAMP 5Subject Matter Expert
• Software Categories	• Software CategoriesSupport	• Software CategoriesPrevious Experience	• Software CategoriesStrong Exdperience	• Software CategoriesSubject Matter Expert
• Firmware	• FirmwareSupport	• FirmwarePrevious Experience	• FirmwareStrong Exdperience	• FirmwareSubject Matter Expert
• Infrastructure Software	• Infrastructure SoftwareSupport	• Infrastructure SoftwarePrevious Experience	• Infrastructure SoftwareStrong Exdperience	• Infrastructure SoftwareSubject Matter Expert
• OTS (non-configured) Software / System	• OTS (non-configured) Software / SystemSupport	• OTS (non-configured) Software / SystemPrevious Experience	• OTS (non-configured) Software / SystemStrong Exdperience	• OTS (non-configured) Software / SystemSubject Matter Expert
• Configurable Software / System	• Configurable Software / SystemSupport	• Configurable Software / SystemPrevious Experience	• Configurable Software / SystemStrong Exdperience	• Configurable Software / SystemSubject Matter Expert
• Custom Software / System	• Custom Software / SystemSupport	• Custom Software / SystemPrevious Experience	• Custom Software / SystemStrong Exdperience	• Custom Software / SystemSubject Matter Expert
• Validation Plan	• Validation PlanSupport	• Validation PlanPrevious Experience	• Validation PlanStrong Exdperience	• Validation PlanSubject Matter Expert
• Verification Test Protocol	• Verification Test ProtocolSupport	• Verification Test ProtocolPrevious Experience	• Verification Test ProtocolStrong Exdperience	• Verification Test ProtocolSubject Matter Expert
• Deviations / Events	• Deviations / EventsSupport	• Deviations / EventsPrevious Experience	• Deviations / EventsStrong Exdperience	• Deviations / EventsSubject Matter Expert
• Corrective Actions	• Corrective ActionsSupport	• Corrective ActionsPrevious Experience	• Corrective ActionsStrong Exdperience	• Corrective ActionsSubject Matter Expert
• Root Cause Analysis	• Root Cause AnalysisSupport	• Root Cause AnalysisPrevious Experience	• Root Cause AnalysisStrong Exdperience	• Root Cause AnalysisSubject Matter Expert
• Impact Assessment	• Impact AssessmentSupport	• Impact AssessmentPrevious Experience	• Impact AssessmentStrong Exdperience	• Impact AssessmentSubject Matter Expert
• User/Functional Requirements	• User/Functional RequirementsSupport	• User/Functional RequirementsPrevious Experience	• User/Functional RequirementsStrong Exdperience	• User/Functional RequirementsSubject Matter Expert
• Design Specifications	• Design SpecificationsSupport	• Design SpecificationsPrevious Experience	• Design SpecificationsStrong Exdperience	• Design SpecificationsSubject Matter Expert
• Design Qualification (DQ)	• Design Qualification (DQ)Support	• Design Qualification (DQ)Previous Experience	• Design Qualification (DQ)Strong Exdperience	• Design Qualification (DQ)Subject Matter Expert
• ERES Assessment	• ERES AssessmentSupport	• ERES AssessmentPrevious Experience	• ERES AssessmentStrong Exdperience	• ERES AssessmentSubject Matter Expert
• Supplier Assessment	• Supplier AssessmentSupport	• Supplier AssessmentPrevious Experience	• Supplier AssessmentStrong Exdperience	• Supplier AssessmentSubject Matter Expert
• Change Request	• Change RequestSupport	• Change RequestPrevious Experience	• Change RequestStrong Exdperience	• Change RequestSubject Matter Expert
• Software Installation Protocol	• Software Installation ProtocolSupport	• Software Installation ProtocolPrevious Experience	• Software Installation ProtocolStrong Exdperience	• Software Installation ProtocolSubject Matter Expert
• Factory Acceptance Test (FAT)	• Factory Acceptance Test (FAT)Support	• Factory Acceptance Test (FAT)Previous Experience	• Factory Acceptance Test (FAT)Strong Exdperience	• Factory Acceptance Test (FAT)Subject Matter Expert
• Site Acceptance Test (SAT)	• Site Acceptance Test (SAT)Support	• Site Acceptance Test (SAT)Previous Experience	• Site Acceptance Test (SAT)Strong Exdperience	• Site Acceptance Test (SAT)Subject Matter Expert
• Computer System Installation Qualification	• Computer System Installation Qualification Support	• Computer System Installation Qualification Previous Experience	• Computer System Installation Qualification Strong Exdperience	• Computer System Installation Qualification Subject Matter Expert
• Computer System Operational Qualification	• Computer System Operational QualificationSupport	• Computer System Operational QualificationPrevious Experience	• Computer System Operational QualificationStrong Exdperience	• Computer System Operational QualificationSubject Matter Expert
• Computer System Performance Qualification	• Computer System Performance Qualification Support	• Computer System Performance Qualification Previous Experience	• Computer System Performance Qualification Strong Exdperience	• Computer System Performance Qualification Subject Matter Expert
• Traceability Matrix	• Traceability Matrix Support	• Traceability Matrix Previous Experience	• Traceability Matrix Strong Exdperience	• Traceability Matrix Subject Matter Expert
• SOP’s	• SOP’sSupport	• SOP’sPrevious Experience	• SOP’sStrong Exdperience	• SOP’sSubject Matter Expert
• Graphical User Interface (GUI)	• Graphical User Interface (GUI)Support	• Graphical User Interface (GUI)Previous Experience	• Graphical User Interface (GUI)Strong Exdperience	• Graphical User Interface (GUI)Subject Matter Expert
• Human-Machine Interface (HMI)	• Human-Machine Interface (HMI)Support	• Human-Machine Interface (HMI)Previous Experience	• Human-Machine Interface (HMI)Strong Exdperience	• Human-Machine Interface (HMI)Subject Matter Expert
• Source Code Review	• Source Code ReviewSupport	• Source Code ReviewPrevious Experience	• Source Code ReviewStrong Exdperience	• Source Code ReviewSubject Matter Expert
• Client Server Applications	• Client Server ApplicationsSupport	• Client Server ApplicationsPrevious Experience	• Client Server ApplicationsStrong Exdperience	• Client Server ApplicationsSubject Matter Expert
• Stand Alone Applications	• Stand Alone ApplicationsSupport	• Stand Alone ApplicationsPrevious Experience	• Stand Alone ApplicationsStrong Exdperience	• Stand Alone ApplicationsSubject Matter Expert
• Web-based/Enterprise Applications	• Web-based/Enterprise ApplicationsSupport	• Web-based/Enterprise ApplicationsPrevious Experience	• Web-based/Enterprise ApplicationsStrong Exdperience	• Web-based/Enterprise ApplicationsSubject Matter Expert
• System Security	• System SecuritySupport	• System SecurityPrevious Experience	• System SecurityStrong Exdperience	• System SecuritySubject Matter Expert
• Backup and Restore/Disaster Recovery	• Backup and Restore/Disaster RecoverySupport	• Backup and Restore/Disaster RecoveryPrevious Experience	• Backup and Restore/Disaster RecoveryStrong Exdperience	• Backup and Restore/Disaster RecoverySubject Matter Expert
• Risk Base Project Plan (RBP)	• Risk Base Project Plan (RBP)Support	• Risk Base Project Plan (RBP)Previous Experience	• Risk Base Project Plan (RBP)Strong Exdperience	• Risk Base Project Plan (RBP)Subject Matter Expert
• Risk Level	• Risk LevelSupport	• Risk LevelPrevious Experience	• Risk LevelStrong Exdperience	• Risk LevelSubject Matter Expert
• Risk Criticality	• Risk CriticalitySupport	• Risk CriticalityPrevious Experience	• Risk CriticalityStrong Exdperience	• Risk CriticalitySubject Matter Expert
• Software Version Verification	• Software Version VerificationSupport	• Software Version VerificationPrevious Experience	• Software Version VerificationStrong Exdperience	• Software Version VerificationSubject Matter Expert
• Periodic Reviews	• Periodic ReviewsSupport	• Periodic ReviewsPrevious Experience	• Periodic ReviewsStrong Exdperience	• Periodic ReviewsSubject Matter Expert
• System Interface Verification	• System Interface VerificationSupport	• System Interface VerificationPrevious Experience	• System Interface VerificationStrong Exdperience	• System Interface VerificationSubject Matter Expert
• Input / Output Testing	• Input / Output TestingSupport	• Input / Output TestingPrevious Experience	• Input / Output TestingStrong Exdperience	• Input / Output TestingSubject Matter Expert
• Signal Simulation	• Signal SimulationSupport	• Signal SimulationPrevious Experience	• Signal SimulationStrong Exdperience	• Signal SimulationSubject Matter Expert
• Alarms Testing	• Alarms TestingSupport	• Alarms TestingPrevious Experience	• Alarms TestingStrong Exdperience	• Alarms TestingSubject Matter Expert
• Field Boundaries	• Field Boundaries Support	• Field Boundaries Previous Experience	• Field Boundaries Strong Exdperience	• Field Boundaries Subject Matter Expert
• User Access Levels	• User Access LevelsSupport	• User Access LevelsPrevious Experience	• User Access LevelsStrong Exdperience	• User Access LevelsSubject Matter Expert
• Open System	• Open SystemSupport	• Open SystemPrevious Experience	• Open SystemStrong Exdperience	• Open SystemSubject Matter Expert
• Closed System	• Closed SystemSupport	• Closed SystemPrevious Experience	• Closed SystemStrong Exdperience	• Closed SystemSubject Matter Expert
• Vendor Assessments	• Vendor AssessmentsSupport	• Vendor AssessmentsPrevious Experience	• Vendor AssessmentsStrong Exdperience	• Vendor AssessmentsSubject Matter Expert
• Software Compare Verification	• Software Compare VerificationSupport	• Software Compare VerificationPrevious Experience	• Software Compare VerificationStrong Exdperience	• Software Compare VerificationSubject Matter Expert
• Summary/Final Report	• Summary/Final ReportSupport	• Summary/Final ReportPrevious Experience	• Summary/Final ReportStrong Exdperience	• Summary/Final ReportSubject Matter Expert
• Risk Assessment	• Risk AssessmentSupport	• Risk AssessmentPrevious Experience	• Risk AssessmentStrong Exdperience	• Risk AssessmentSubject Matter Expert
• Commissioning	• Commissioning Support	• Commissioning Previous Experience	• Commissioning Strong Exdperience	• Commissioning Subject Matter Expert
• Decommissioning	• Decommissioning Support	• Decommissioning Previous Experience	• Decommissioning Strong Exdperience	• Decommissioning Subject Matter Expert
• Delta V and operation in qualification	• Delta V and operation in qualificationSupport	• Delta V and operation in qualificationPrevious Experience	• Delta V and operation in qualificationStrong Exdperience	• Delta V and operation in qualificationSubject Matter Expert
• Serialization	• SerializationSupport	• SerializationPrevious Experience	• SerializationStrong Exdperience	• SerializationSubject Matter Expert
• Safety Devices: Interlocks and alarms	• Safety Devices: Interlocks and alarmsSupport	• Safety Devices: Interlocks and alarmsPrevious Experience	• Safety Devices: Interlocks and alarmsStrong Exdperience	• Safety Devices: Interlocks and alarmsSubject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Exdperience	• Other:Subject Matter Expert

Parenterals/Ophthalmics
Parenterals/Ophthalmics	Support	Previous Experience	Strong Exdperience	Subject Matter Expert
• Lyophilizers	• LyophilizersSupport	• LyophilizersPrevious Experience	• LyophilizersStrong Exdperience	• LyophilizersSubject Matter Expert
• Depyrogenators (including load patterns)	• Depyrogenators (including load patterns)Support	• Depyrogenators (including load patterns)Previous Experience	• Depyrogenators (including load patterns)Strong Exdperience	• Depyrogenators (including load patterns)Subject Matter Expert
• Autoclave (including load patterns)	• Autoclave (including load patterns)Support	• Autoclave (including load patterns)Previous Experience	• Autoclave (including load patterns)Strong Exdperience	• Autoclave (including load patterns)Subject Matter Expert
• Vial Washers	• Vial WashersSupport	• Vial WashersPrevious Experience	• Vial WashersStrong Exdperience	• Vial WashersSubject Matter Expert
• Filling Lines	• Filling LinesSupport	• Filling LinesPrevious Experience	• Filling LinesStrong Exdperience	• Filling LinesSubject Matter Expert
• Gamma Irradiation	• Gamma IrradiationSupport	• Gamma IrradiationPrevious Experience	• Gamma IrradiationStrong Exdperience	• Gamma IrradiationSubject Matter Expert
• Terminal Sterilization	• Terminal SterilizationSupport	• Terminal SterilizationPrevious Experience	• Terminal SterilizationStrong Exdperience	• Terminal SterilizationSubject Matter Expert
• ETO Sterilization	• ETO SterilizationSupport	• ETO SterilizationPrevious Experience	• ETO SterilizationStrong Exdperience	• ETO SterilizationSubject Matter Expert
• Compounding Operations	• Compounding OperationsSupport	• Compounding OperationsPrevious Experience	• Compounding OperationsStrong Exdperience	• Compounding OperationsSubject Matter Expert
• Freezers	• FreezersSupport	• FreezersPrevious Experience	• FreezersStrong Exdperience	• FreezersSubject Matter Expert
• Incubators/Environmental Chambers	• Incubators/Environmental ChambersSupport	• Incubators/Environmental ChambersPrevious Experience	• Incubators/Environmental ChambersStrong Exdperience	• Incubators/Environmental ChambersSubject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Exdperience	• Other:Subject Matter Expert

Packaging
Packaging	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Labelers	• LabelersSupport	• LabelersPrevious Experience	• LabelersStrong Experience	• LabelersSubject Matter Expert
• Metal Detector	• Metal DetectorSupport	• Metal DetectorPrevious Experience	• Metal DetectorStrong Experience	• Metal DetectorSubject Matter Expert
• Unscrambler machine	• Unscrambler machineSupport	• Unscrambler machinePrevious Experience	• Unscrambler machineStrong Experience	• Unscrambler machineSubject Matter Expert
• Un-scrambler/machine/bottle blower	• Un-scrambler/machine/bottle blowerSupport	• Un-scrambler/machine/bottle blowerPrevious Experience	• Un-scrambler/machine/bottle blowerStrong Experience	• Un-scrambler/machine/bottle blowerSubject Matter Expert
• Desiccant Feeder	• Desiccant FeederSupport	• Desiccant FeederPrevious Experience	• Desiccant FeederStrong Experience	• Desiccant FeederSubject Matter Expert
• Vision Systems	• Vision SystemsSupport	• Vision SystemsPrevious Experience	• Vision SystemsStrong Experience	• Vision SystemsSubject Matter Expert
• Case Packers	• Case PackersSupport	• Case PackersPrevious Experience	• Case PackersStrong Experience	• Case PackersSubject Matter Expert
• Cap Re-torquer	• Cap Re-torquerSupport	• Cap Re-torquerPrevious Experience	• Cap Re-torquerStrong Experience	• Cap Re-torquerSubject Matter Expert
• Cartoners	• CartonersSupport	• CartonersPrevious Experience	• CartonersStrong Experience	• CartonersSubject Matter Expert
• Checkweighers	• CheckweighersSupport	• CheckweighersPrevious Experience	• CheckweighersStrong Experience	• CheckweighersSubject Matter Expert
• Cottonners	• CottonnersSupport	• CottonnersPrevious Experience	• CottonnersStrong Experience	• CottonnersSubject Matter Expert
• Fillers	• FillersSupport	• FillersPrevious Experience	• FillersStrong Experience	• FillersSubject Matter Expert
• Removable Capper	• Removable CapperSupport	• Removable CapperPrevious Experience	• Removable CapperStrong Experience	• Removable CapperSubject Matter Expert
• Cappers	• CappersSupport	• CappersPrevious Experience	• CappersStrong Experience	• CappersSubject Matter Expert
• Overwrapper Machines	• Overwrapper MachinesSupport	• Overwrapper MachinesPrevious Experience	• Overwrapper MachinesStrong Experience	• Overwrapper MachinesSubject Matter Expert
• Embossing Machines	• Embossing MachinesSupport	• Embossing MachinesPrevious Experience	• Embossing MachinesStrong Experience	• Embossing MachinesSubject Matter Expert
• Neckbanders	• NeckbandersSupport	• NeckbandersPrevious Experience	• NeckbandersStrong Experience	• NeckbandersSubject Matter Expert
• Printers	• PrintersSupport	• PrintersPrevious Experience	• PrintersStrong Experience	• PrintersSubject Matter Expert
• Westcapper	• WestcapperSupport	• WestcapperPrevious Experience	• WestcapperStrong Experience	• WestcapperSubject Matter Expert
• Seal Force Monitor	• Seal Force MonitorSupport	• Seal Force MonitorPrevious Experience	• Seal Force MonitorStrong Experience	• Seal Force MonitorSubject Matter Expert
• Blister Machines	• Blister MachinesSupport	• Blister MachinesPrevious Experience	• Blister MachinesStrong Experience	• Blister MachinesSubject Matter Expert
• Thermoformer	• ThermoformerSupport	• ThermoformerPrevious Experience	• ThermoformerStrong Experience	• ThermoformerSubject Matter Expert
• Induction Sealer	• Induction SealerSupport	• Induction SealerPrevious Experience	• Induction SealerStrong Experience	• Induction SealerSubject Matter Expert
• Others:	• Others:Support	• Others:Previous Experience	• Others:Strong Experience	• Others:Subject Matter Expert

Process Validation	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Process Validation Solids Dosage Operations (Wet Granulation)	• Process Validation Solids Dosage Operations (Wet Granulation)Support	• Process Validation Solids Dosage Operations (Wet Granulation)Previous Experience	• Process Validation Solids Dosage Operations (Wet Granulation)Strong Experience	• Process Validation Solids Dosage Operations (Wet Granulation)Subject Matter Expert
• Process Validation Solids Dosage Operations (Dry Granulation)	• Process Validation Solids Dosage Operations (Dry Granulation) Support	• Process Validation Solids Dosage Operations (Dry Granulation) Previous Experience	• Process Validation Solids Dosage Operations (Dry Granulation) Strong Experience	• Process Validation Solids Dosage Operations (Dry Granulation) Subject Matter Expert
• Semi-solids Process Manufacturing Operations	• Semi-solids Process Manufacturing OperationsSupport	• Semi-solids Process Manufacturing OperationsPrevious Experience	• Semi-solids Process Manufacturing OperationsStrong Experience	• Semi-solids Process Manufacturing OperationsSubject Matter Expert
• Oral Suspension Process Manufacturing Operations	• Oral Suspension Process Manufacturing OperationsSupport	• Oral Suspension Process Manufacturing OperationsPrevious Experience	• Oral Suspension Process Manufacturing OperationsStrong Experience	• Oral Suspension Process Manufacturing OperationsSubject Matter Expert
• Aseptic Process Manufacturing Operations	• Aseptic Process Manufacturing OperationsSupport	• Aseptic Process Manufacturing OperationsPrevious Experience	• Aseptic Process Manufacturing OperationsStrong Experience	• Aseptic Process Manufacturing OperationsSubject Matter Expert
• Biotechnology Process Manufacturing Operations	• Biotechnology Process Manufacturing OperationsSupport	• Biotechnology Process Manufacturing OperationsPrevious Experience	• Biotechnology Process Manufacturing OperationsStrong Experience	• Biotechnology Process Manufacturing OperationsSubject Matter Expert
• Transfer of pharmaceutical processes and products	• Transfer of pharmaceutical processes and productsSupport	• Transfer of pharmaceutical processes and productsPrevious Experience	• Transfer of pharmaceutical processes and productsStrong Experience	• Transfer of pharmaceutical processes and productsSubject Matter Expert
• Process Changes on API, Raw Materials, Manufacturing Equipment, etc.	• Process Changes on API, Raw Materials, Manufacturing Equipment, etc.Support	• Process Changes on API, Raw Materials, Manufacturing Equipment, etc.Previous Experience	• Process Changes on API, Raw Materials, Manufacturing Equipment, etc.Strong Experience	• Process Changes on API, Raw Materials, Manufacturing Equipment, etc.Subject Matter Expert
• Manufacturing Sampling Techniques (i.e. Granulation Sampling Thief, Compression, Coating, Formulation Tanks, etc.)	• Manufacturing Sampling Techniques (i.e. Granulation Sampling Thief, Compression, Coating, Formulation Tanks, etc.)Support	• Manufacturing Sampling Techniques (i.e. Granulation Sampling Thief, Compression, Coating, Formulation Tanks, etc.)Previous Experience	• Manufacturing Sampling Techniques (i.e. Granulation Sampling Thief, Compression, Coating, Formulation Tanks, etc.)Strong Experience	• Manufacturing Sampling Techniques (i.e. Granulation Sampling Thief, Compression, Coating, Formulation Tanks, etc.)Subject Matter Expert
• Batch Records Preparation and Revision	• Batch Records Preparation and RevisionSupport	• Batch Records Preparation and RevisionPrevious Experience	• Batch Records Preparation and RevisionStrong Experience	• Batch Records Preparation and RevisionSubject Matter Expert
• Holding (Staging) Times Study	• Holding (Staging) Times StudySupport	• Holding (Staging) Times StudyPrevious Experience	• Holding (Staging) Times StudyStrong Experience	• Holding (Staging) Times StudySubject Matter Expert
• Manufacturing Investigations	• Manufacturing InvestigationsSupport	• Manufacturing InvestigationsPrevious Experience	• Manufacturing InvestigationsStrong Experience	• Manufacturing InvestigationsSubject Matter Expert
• Product Complaints	• Product ComplaintsSupport	• Product ComplaintsPrevious Experience	• Product ComplaintsStrong Experience	• Product ComplaintsSubject Matter Expert
• Technical Assessment	• Technical AssessmentSupport	• Technical AssessmentPrevious Experience	• Technical AssessmentStrong Experience	• Technical AssessmentSubject Matter Expert
• Shipping Study	• Shipping StudySupport	• Shipping StudyPrevious Experience	• Shipping StudyStrong Experience	• Shipping StudySubject Matter Expert
• Process Validation Protocol and Report	• Process Validation Protocol and ReportSupport	• Process Validation Protocol and ReportPrevious Experience	• Process Validation Protocol and ReportStrong Experience	• Process Validation Protocol and ReportSubject Matter Expert
• Other	• OtherSupport	• OtherPrevious Experience	• OtherStrong Experience	• OtherSubject Matter Expert

Project Management	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Lead the planning and implementation of project; facilitate the definition of project scope, goals and deliverable.	• Lead the planning and implementation of project; facilitate the definition of project scope, goals and deliverable.Support	• Lead the planning and implementation of project; facilitate the definition of project scope, goals and deliverable.Previous Experience	• Lead the planning and implementation of project; facilitate the definition of project scope, goals and deliverable.Strong Experience	• Lead the planning and implementation of project; facilitate the definition of project scope, goals and deliverable.Subject Matter Expert
• Assign and distribute work load	• Assign and distribute work loadSupport	• Assign and distribute work loadPrevious Experience	• Assign and distribute work loadStrong Experience	• Assign and distribute work loadSubject Matter Expert
• Preparation of Project Status Reports	• Preparation of Project Status ReportsSupport	• Preparation of Project Status ReportsPrevious Experience	• Preparation of Project Status ReportsStrong Experience	• Preparation of Project Status ReportsSubject Matter Expert
• Preparation and follow-up of Project Schedules using Microsoft Project application	• Preparation and follow-up of Project Schedules using Microsoft Project applicationSupport	• Preparation and follow-up of Project Schedules using Microsoft Project applicationPrevious Experience	• Preparation and follow-up of Project Schedules using Microsoft Project applicationStrong Experience	• Preparation and follow-up of Project Schedules using Microsoft Project applicationSubject Matter Expert
• Participate in Project Status Meeting	• Participate in Project Status MeetingSupport	• Participate in Project Status MeetingPrevious Experience	• Participate in Project Status MeetingStrong Experience	• Participate in Project Status MeetingSubject Matter Expert
• Creates and executes project work plans and revises as appropriate to meet changing needs and requirements	• Creates and executes project work plans and revises as appropriate to meet changing needs and requirementsSupport	• Creates and executes project work plans and revises as appropriate to meet changing needs and requirementsPrevious Experience	• Creates and executes project work plans and revises as appropriate to meet changing needs and requirementsStrong Experience	• Creates and executes project work plans and revises as appropriate to meet changing needs and requirementsSubject Matter Expert
• Interview and select candidates. Identifies resources needed and assigns individual responsibilities	• Interview and select candidates. Identifies resources needed and assigns individual responsibilitiesSupport	• Interview and select candidates. Identifies resources needed and assigns individual responsibilitiesPrevious Experience	• Interview and select candidates. Identifies resources needed and assigns individual responsibilitiesStrong Experience	• Interview and select candidates. Identifies resources needed and assigns individual responsibilitiesSubject Matter Expert
• Commissioning and Qualification Methodology	• Commissioning and Qualification MethodologySupport	• Commissioning and Qualification MethodologyPrevious Experience	• Commissioning and Qualification MethodologyStrong Experience	• Commissioning and Qualification MethodologySubject Matter Expert
• Manages day-to-day operational aspects of a project and scope	• Manages day-to-day operational aspects of a project and scopeSupport	• Manages day-to-day operational aspects of a project and scopePrevious Experience	• Manages day-to-day operational aspects of a project and scopeStrong Experience	• Manages day-to-day operational aspects of a project and scopeSubject Matter Expert
• Reviews deliverables prepared by team before passing to client	• Reviews deliverables prepared by team before passing to clientSupport	• Reviews deliverables prepared by team before passing to clientPrevious Experience	• Reviews deliverables prepared by team before passing to clientStrong Experience	• Reviews deliverables prepared by team before passing to clientSubject Matter Expert
• Effectively applies methodology and enforces project standards	• Effectively applies methodology and enforces project standardsSupport	• Effectively applies methodology and enforces project standardsPrevious Experience	• Effectively applies methodology and enforces project standardsStrong Experience	• Effectively applies methodology and enforces project standardsSubject Matter Expert
• Reviews deliverables prepared by team before passing to client	• Reviews deliverables prepared by team before passing to clientSupport	• Reviews deliverables prepared by team before passing to clientPrevious Experience	• Reviews deliverables prepared by team before passing to clientStrong Experience	• Reviews deliverables prepared by team before passing to clientSubject Matter Expert
• Minimizes exposure and risk on project	• Minimizes exposure and risk on projectSupport	• Minimizes exposure and risk on projectPrevious Experience	• Minimizes exposure and risk on projectStrong Experience	• Minimizes exposure and risk on projectSubject Matter Expert
• Ensures project documents are complete, current, and stored appropriately	• Ensures project documents are complete, current, and stored appropriatelySupport	• Ensures project documents are complete, current, and stored appropriatelyPrevious Experience	• Ensures project documents are complete, current, and stored appropriatelyStrong Experience	• Ensures project documents are complete, current, and stored appropriatelySubject Matter Expert
• Negotiation and liaison skills	• Negotiation and liaison skillsSupport	• Negotiation and liaison skillsPrevious Experience	• Negotiation and liaison skillsStrong Experience	• Negotiation and liaison skillsSubject Matter Expert
• English and Spanish verbal and written communication skills	• English and Spanish verbal and written communication skillsSupport	• English and Spanish verbal and written communication skillsPrevious Experience	• English and Spanish verbal and written communication skillsStrong Experience	• English and Spanish verbal and written communication skillsSubject Matter Expert
• Work under pressure and with multiple tasks at the same time	• Work under pressure and with multiple tasks at the same timeSupport	• Work under pressure and with multiple tasks at the same timePrevious Experience	• Work under pressure and with multiple tasks at the same timeStrong Experience	• Work under pressure and with multiple tasks at the same timeSubject Matter Expert
• Present reports defining project progress, problems and solutions	• Present reports defining project progress, problems and solutionsSupport	• Present reports defining project progress, problems and solutionsPrevious Experience	• Present reports defining project progress, problems and solutionsStrong Experience	• Present reports defining project progress, problems and solutionsSubject Matter Expert
• Work flexible hours	• Work flexible hoursSupport	• Work flexible hoursPrevious Experience	• Work flexible hoursStrong Experience	• Work flexible hoursSubject Matter Expert
• Travel inside and outside Puerto Rico	• Travel inside and outside Puerto RicoSupport	• Travel inside and outside Puerto RicoPrevious Experience	• Travel inside and outside Puerto RicoStrong Experience	• Travel inside and outside Puerto RicoSubject Matter Expert
• Implement changes in policies, procedures and standards	• Implement changes in policies, procedures and standardsSupport	• Implement changes in policies, procedures and standardsPrevious Experience	• Implement changes in policies, procedures and standardsStrong Experience	• Implement changes in policies, procedures and standardsSubject Matter Expert
• Provide direction and support to project team	• Provide direction and support to project teamSupport	• Provide direction and support to project teamPrevious Experience	• Provide direction and support to project teamStrong Experience	• Provide direction and support to project teamSubject Matter Expert
• Appoint, dismiss and discipline employees	• Appoint, dismiss and discipline employeesSupport	• Appoint, dismiss and discipline employeesPrevious Experience	• Appoint, dismiss and discipline employeesStrong Experience	• Appoint, dismiss and discipline employeesSubject Matter Expert

Technical Writer	Support	Previous Experience	Strong Experience	Subject Matter Expert
• Create, edit, and maintain technical documentation i.e., user guides, technical reference manuals and production control manuals.	• Create, edit, and maintain technical documentation i.e., user guides, technical reference manuals and production control manuals.Support	• Create, edit, and maintain technical documentation i.e., user guides, technical reference manuals and production control manuals.Previous Experience	• Create, edit, and maintain technical documentation i.e., user guides, technical reference manuals and production control manuals.Strong Experience	• Create, edit, and maintain technical documentation i.e., user guides, technical reference manuals and production control manuals.Subject Matter Expert
• Create, edit, and maintain procedural documentation including but not limited to department policies and procedures	• Create, edit, and maintain procedural documentation including but not limited to department policies and proceduresSupport	• Create, edit, and maintain procedural documentation including but not limited to department policies and proceduresPrevious Experience	• Create, edit, and maintain procedural documentation including but not limited to department policies and proceduresStrong Experience	• Create, edit, and maintain procedural documentation including but not limited to department policies and proceduresSubject Matter Expert
• Write, edit, produce, and maintain on-line (internet/web-based) documentation.	• Write, edit, produce, and maintain on-line (internet/web-based) documentation.Support	• Write, edit, produce, and maintain on-line (internet/web-based) documentation.Previous Experience	• Write, edit, produce, and maintain on-line (internet/web-based) documentation.Strong Experience	• Write, edit, produce, and maintain on-line (internet/web-based) documentation.Subject Matter Expert
• Prepares Validation Data Pack that will consist of all documents related to the qualification process; such as Protocol Data, Report, Raw Data, and reference documents, completed and organized.	• Prepares Validation Data Pack that will consist of all documents related to the qualification process; such as Protocol Data, Report, Raw Data, and reference documents, completed and organized.Support	• Prepares Validation Data Pack that will consist of all documents related to the qualification process; such as Protocol Data, Report, Raw Data, and reference documents, completed and organized.Previous Experience	• Prepares Validation Data Pack that will consist of all documents related to the qualification process; such as Protocol Data, Report, Raw Data, and reference documents, completed and organized.Strong Experience	• Prepares Validation Data Pack that will consist of all documents related to the qualification process; such as Protocol Data, Report, Raw Data, and reference documents, completed and organized.Subject Matter Expert
• Proficiency in the use of Office Programs like Microsoft Word, Power Point, Excel.	• Proficiency in the use of Office Programs like Microsoft Word, Power Point, Excel.Support	• Proficiency in the use of Office Programs like Microsoft Word, Power Point, Excel.Previous Experience	• Proficiency in the use of Office Programs like Microsoft Word, Power Point, Excel.Strong Experience	• Proficiency in the use of Office Programs like Microsoft Word, Power Point, Excel.Subject Matter Expert
• Research and evaluate new equipment, processes and/or methods for document and/or improve documentation processes.	• Research and evaluate new equipment, processes and/or methods for document and/or improve documentation processes.Support	• Research and evaluate new equipment, processes and/or methods for document and/or improve documentation processes.Previous Experience	• Research and evaluate new equipment, processes and/or methods for document and/or improve documentation processes.Strong Experience	• Research and evaluate new equipment, processes and/or methods for document and/or improve documentation processes.Subject Matter Expert
• Ensure accuracy and completeness of technical documentation.	• Ensure accuracy and completeness of technical documentation.Support	• Ensure accuracy and completeness of technical documentation.Previous Experience	• Ensure accuracy and completeness of technical documentation.Strong Experience	• Ensure accuracy and completeness of technical documentation.Subject Matter Expert
• Provide presentations and training.	• Provide presentations and training.Support	• Provide presentations and training.Previous Experience	• Provide presentations and training.Strong Experience	• Provide presentations and training.Subject Matter Expert
• Evaluate and challenge the business systems and applications, process or equipment for which documentation is to be prepared.	• Evaluate and challenge the business systems and applications, process or equipment for which documentation is to be prepared.Support	• Evaluate and challenge the business systems and applications, process or equipment for which documentation is to be prepared.Previous Experience	• Evaluate and challenge the business systems and applications, process or equipment for which documentation is to be prepared.Strong Experience	• Evaluate and challenge the business systems and applications, process or equipment for which documentation is to be prepared.Subject Matter Expert
• Meet developers, owners, mechanics, engineers and managers to clarify technical issues.	• Meet developers, owners, mechanics, engineers and managers to clarify technical issues.Support	• Meet developers, owners, mechanics, engineers and managers to clarify technical issues.Previous Experience	• Meet developers, owners, mechanics, engineers and managers to clarify technical issues.Strong Experience	• Meet developers, owners, mechanics, engineers and managers to clarify technical issues.Subject Matter Expert
• Assures that all documentation is properly distributed, reviewed and approved in accordance with the Project Scope Document.	• Assures that all documentation is properly distributed, reviewed and approved in accordance with the Project Scope Document.Support	• Assures that all documentation is properly distributed, reviewed and approved in accordance with the Project Scope Document.Previous Experience	• Assures that all documentation is properly distributed, reviewed and approved in accordance with the Project Scope Document.Strong Experience	• Assures that all documentation is properly distributed, reviewed and approved in accordance with the Project Scope Document.Subject Matter Expert
• Tests documentation to ensure that it matches the finished product, process or system.	• Tests documentation to ensure that it matches the finished product, process or system.Support	• Tests documentation to ensure that it matches the finished product, process or system.Previous Experience	• Tests documentation to ensure that it matches the finished product, process or system.Strong Experience	• Tests documentation to ensure that it matches the finished product, process or system.Subject Matter Expert
• Write and implement Change Control Requests	• Write and implement Change Control RequestsSupport	• Write and implement Change Control RequestsPrevious Experience	• Write and implement Change Control RequestsStrong Experience	• Write and implement Change Control RequestsSubject Matter Expert
• Ensures the applicability of the Operating Procedure in the Change Control Program.	• Ensures the applicability of the Operating Procedure in the Change Control Program.Support	• Ensures the applicability of the Operating Procedure in the Change Control Program.Previous Experience	• Ensures the applicability of the Operating Procedure in the Change Control Program.Strong Experience	• Ensures the applicability of the Operating Procedure in the Change Control Program.Subject Matter Expert
• Excellent written and verbal communication skills in English and Spanish	• Excellent written and verbal communication skills in English and SpanishSupport	• Excellent written and verbal communication skills in English and SpanishPrevious Experience	• Excellent written and verbal communication skills in English and SpanishStrong Experience	• Excellent written and verbal communication skills in English and SpanishSubject Matter Expert
• Gather and analyze the information needs of the users.	• Gather and analyze the information needs of the users.Support	• Gather and analyze the information needs of the users.Previous Experience	• Gather and analyze the information needs of the users.Strong Experience	• Gather and analyze the information needs of the users.Subject Matter Expert
• Other:	• Other:Support	• Other:Previous Experience	• Other:Strong Experience	• Other:Subject Matter Expert