CSV Engineer
Job Summary:
- CSV Engineer to support commissioning and validation activities for a newly built Cell & Gene Therapy R&D and manufacturing facility in Pittsburgh, PA.
- The role focuses on reviewing validation deliverables, ensuring compliance with regulatory standards (21 CFR Part 11, GAMP 5), and coordinating with commissioning teams handling facilities, utilities, MES, EMS, CMMS, and related systems.
- The consultant will work within environments using Kneat, Microsoft Office, and automation platforms such as MES and EMS/SMCS.
- Review master validation plans and identify issues (CSV and CQV)
- Verify scope, strategy, and acceptance criteria
- Execute IQ/OQ/PQ protocols supporting commissioning of MES, Client, and associated equipment
- Review commissioning and qualification protocols for CSV and CQV
- Review functional and design specifications
- Review SAT and FAT documentation
- Review IQ/OQ/PQ protocols for URS alignment and accuracy
- Ensure compliance with 21 CFR Part 11 and GAMP 5 (audit trails, access control, e-signatures)
- Perform gap analysis of commissioning documentation to identify risks and deviations
- Act as liaison between commissioning firm and internal Engineering, Quality, and IT teams
- Review change control records and documentation
- Manage validation data using Kneat
- Support validation of MES, Client, EMS, or SMCS systems (e.g., SCADA, PLC, MES)
- Create and execute CSV protocols
- Manage traceability matrices
- Create summary reports for approval
- Manage deviations
- Review FAT and SAT data for GMP compliance
- Review automation system URS documentation
- Previous experience as a CSV Engineer supporting commissioning activities on life sciences construction projects (Greenfield or Brownfield)
- Experience using Kneat for validation data management
- Experience validating MES, Client, EMS, or SMCS systems
- Experience creating/executing CSV IQ/OQ/PQ protocols
- Experience managing traceability matrices
- Experience preparing validation summary reports
- Experience managing deviations
- Experience reviewing FAT and SAT data
- Experience reviewing automation URS documents
