Senior Specialist, Engineering Commissioning, Qualification and Validation (CQV)
Core
Own the qualification of process/utility equipment and validation of computerized systems controlling them, from commissioning/start-up through routine operation, ensuring compliance with regulatory standards.
Role type
Senior Specialist, Engineering Commissioning, Qualification and Validation (CQV)
Builds
Qualified and validated process/utility equipment and computerized systems for biologics and sterile drug product manufacturing.
Domain
Biopharmaceutical manufacturing (Biologics and Sterile Drug Products)
Required skills
Equipment qualification (IQ/OQ/PQ), Computer System Validation (CSV), Risk-based validation strategies, Regulatory compliance (FDA/EMA/ICH), Data integrity (21 CFR Part 11), Technical writing, Root cause analysis, Change management
Preferred skills
Biologics manufacturing environment experience, Start-up facility experience, DeltaV/MES/SAP systems familiarity
Technologies
GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, Microsoft Office, DeltaV, MES, SAP
Responsibilities
Develop CQV plans and risk-based strategies; Author and execute IQ/OQ/PQ protocols; Manage CSV deliverables (URS, FS, DS, traceability matrices); Ensure compliance with regulatory requirements; Assess impact of changes/deviations; Maintain audit-ready documentation; Participate in CAPA and root cause analysis; Coach colleagues on CQV processes.
Seniority
Senior, hands-on IC