Qualification Engineer
Core
Plan, coordinate, execute, and document commissioning, qualification, and requalification activities for manufacturing equipment, utilities, facilities, HVAC, cleanrooms, and environmental-control systems to ensure compliance and safety.
Role type
Senior IC qualification engineer (pharmaceutical manufacturing)
Builds
Audit-ready qualification records, IQ/OQ/PQ protocols, and system acceptance documentation
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
GMP compliance, IQ/OQ/PQ execution, change control management, risk assessment, technical documentation, system acceptance testing, CAPA support, audit preparation, traceability management, regulatory inspection readiness
Preferred skills
Pharmaceutical industry experience, hands-on qualification of utilities/HVAC/cleanrooms, FAT/SAT coordination, cross-functional project team leadership, regulatory investigation support, project management, data integrity training
Technologies
Microsoft Office, electronic document systems, change-control systems, maintenance systems
Responsibilities
Plan and execute commissioning and qualification activities for equipment and facilities; Prepare and maintain lifecycle documents including qualification plans and IQ/OQ protocols; Coordinate change controls and assess qualification impacts; Conduct field verification and challenge testing; Support engineering capital projects from design through handover; Review technical specifications and test records against GMP requirements; Maintain qualification-status tracking and support periodic requalification; Participate in audits and regulatory inspections; Develop qualification-related SOPs and work instructions
Seniority
Mid-level, hands-on IC