Senior Specialist, Engineering Commissioning, Qualification and Validation (CQV)
Core
Own the qualification of process/utility equipment and validation of computerized systems from commissioning through routine operation in biologics and sterile drug product facilities.
Role type
Senior Specialist, Engineering CQV (Commissioning, Qualification, Validation)
Builds
Qualified and validated process/utility equipment and computerized systems for biologics and sterile drug product manufacturing
Domain
Biopharmaceutical manufacturing (Biologics, Sterile Drug Products)
Required skills
Equipment qualification (IQ/OQ/PQ), Computer Systems Validation (CSV), GAMP 5, 21 CFR Part 11, EU Annex 11, Risk-based validation, Regulatory compliance (FDA/EMA/ICH), Technical writing, Root cause analysis
Preferred skills
Biologics manufacturing experience, Start-up facility experience, DeltaV, MES, SAP
Technologies
DeltaV, MES, SAP, Microsoft Office
Responsibilities
Develop CQV plans and risk-based strategies; Author and execute IQ/OQ/PQ protocols; Manage CSV deliverables (URS, FS, DS, traceability); Ensure compliance with 21 CFR Part 11 and EU Annex 11; Assess impact of changes/deviations; Maintain audit-ready documentation; Participate in CAPA and root cause analysis; Coach colleagues on CQV processes.
Seniority
Senior Specialist, hands-on IC