Validation Engineer

My client is looking for an experienced Senior CQV Engineer to support commissioning, qualification, validation, and cycle development activities across GMP pharmaceutical manufacturing facilities. This role will focus heavily on autoclave cycle development, sterilization processes, equipment qualification, and commissioning activities within sterile manufacturing environments.

The successful candidate will have extensive experience executing CQV projects for critical process equipment and utilities, alongside hands‑on experience developing, optimizing, and qualifying autoclave and washer cycles in regulated pharmaceutical facilities.

• Lead commissioning, qualification, and validation activities for GMP manufacturing equipment and utilities.
• Develop and execute IQ, OQ, and PQ protocols for process equipment and sterilization systems.
• Perform autoclave cycle development, optimization, troubleshooting, and qualification activities.
• Support qualification of equipment washers, rack washers, CIP/COP systems, and sterilization equipment.
• Execute FATs, SATs, commissioning activities, and system walkdowns.
• Review and approve turnover packages, P&IDs, engineering documentation, and vendor deliverables.
• Conduct risk assessments and support ASTM E2500 verification approaches.
• Generate and review validation documentation including URS, FS, RTM, SOPs, and qualification reports.
• Support cleanroom, facility, and utility qualification activities.
• Collaborate with Manufacturing, Engineering, Quality, and Validation teams to ensure GMP compliance.

• Bachelor's degree in Engineering or related technical discipline.
• 8+ years of CQV, Validation, or Qualification experience within pharmaceutical, biotech, or biologics manufacturing.
• Demonstrated experience developing and qualifying autoclave sterilization cycles.
• Experience with equipment washers, rack washers, CIP/COP systems, and sterilization processes.
• Strong knowledge of IQ, OQ, PQ execution and lifecycle validation activities.
• Experience with FAT/SAT execution and equipment commissioning.
• Familiarity with GMP regulations, FDA requirements, ISPE guidance, and ASTM E2500 methodologies.
• Experience working within sterile manufacturing, aseptic processing, biologics, cell therapy, or vaccine production facilities.