Manager, Senior Engineer Engineering Commissioning, Qualification & Validation
Core
Lead equipment qualification and requalification (IQ/OQ/PQ) strategies for biologics manufacturing facilities to ensure compliance and operational readiness.
Role type
Manager, Engineering Commissioning, Qualification & Validation (CQV)
Builds
Qualified and requalified equipment for Multi-Product Cell Culture and Sterile Drug Product Facility operations
Domain
Biologics / Pharmaceutical manufacturing
Required skills
Equipment qualification (IQ/OQ/PQ), GMP compliance, risk assessment, change control, regulatory strategy (FDA/EMA/ICH), team leadership, technical writing
Preferred skills
Multi-facility campus management, vendor management, audit support, process improvement
Technologies
GMP, FDA, EMA, ICH, ISPE Baseline Guides
Responsibilities
Develop and implement equipment qualification and requalification strategies; manage periodic requalification programs; author and review qualification protocols and reports; conduct risk assessments and develop mitigation strategies; collaborate with cross-functional teams for operational handover; provide training and mentorship to specialists; support internal and external audits.
Seniority
Manager, hands-on IC with team leadership