Manager, Engineering Commissioning Qualification & Validation
Core
Lead commissioning, qualification (IQ/OQ/PQ), and requalification of critical facility and process utilities (HVAC, WFI, steam, air, CIP/SIP) across biologics and sterile drug product facilities.
Role type
Manager, Engineering CQV (Facility & Process Utilities)
Builds
Qualified and validated facility utilities and HVAC systems for Multi-Product Cell Culture and Sterile Drug Product facilities
Domain
Biologics/Pharmaceutical manufacturing (GMP)
Required skills
Commissioning and Qualification (IQ/OQ/PQ) of facility utilities, HVAC system validation, GMP regulatory compliance (FDA/EMA/ICH), risk assessment and mitigation, change control management, technical writing for protocols and reports, cross-functional stakeholder management, team leadership and mentorship
Preferred skills
Experience with biologics facility operations, familiarity with cleanroom classification and environmental monitoring, process improvement and optimization
Technologies
HVAC systems, WFI, purified water, clean steam, compressed air, CIP/SIP skids, BMS/EMS, ISPE Baseline Guide Vol. 5, ASTM E2500
Responsibilities
Develop and implement utilities qualification strategies and master plans; oversee commissioning and start-up activities; author and review URS, DQ, IQ/OQ/PQ protocols and reports; conduct risk assessments and develop mitigation strategies; collaborate with cross-functional teams to align qualification activities with project objectives; manage change control processes for utilities and HVAC; oversee environmental monitoring qualification and cleanroom classification; provide training and performance management to team members; support internal and external audits and inspections.
Seniority
Manager, hands-on IC with team leadership