Sector: Pharmaceutical Manufacturing / Life Sciences
Location: USA / International
Overview:
The Commissioning Manager is responsible for planning, coordinating, and executing commissioning, qualification, and startup activities for pharmaceutical facilities, utilities, process equipment, and cleanroom systems. The role ensures compliance with GMP, FDA, and regulatory requirements while supporting successful project delivery and operational readiness.
Key Responsibilities:
- Lead commissioning and startup activities for pharmaceutical manufacturing facilities.
- Manage Commissioning, Qualification, and Validation (CQV) programs.
- Coordinate commissioning of process equipment, clean utilities, HVAC, cleanrooms, and automation systems.
- Develop commissioning plans, protocols, schedules, and turnover packages.
- Oversee FAT, SAT, IQ, OQ, and support PQ activities.
- Ensure compliance with GMP, FDA, ISPE, and project quality standards.
- Coordinate contractors, vendors, engineering teams, validation teams, and operations.
- Manage punch lists, deviations, and commissioning documentation.
- Support facility handover and operational readiness.
Requirements:
- Degree in Mechanical, Chemical, Electrical, Industrial Engineering, or related field.
- 10+ years of experience in pharmaceutical, biotech, or life sciences projects.
- Strong experience in commissioning, qualification, validation, and startup activities.
- Knowledge of GMP, FDA regulations, ISPE guidelines, and CQV methodologies.
- Experience with cleanrooms, HVAC, purified water, WFI, clean steam, and process systems.
Key Skills:
Commissioning Management, CQV, GMP, FDA Compliance, HVAC Commissioning, Cleanroom Qualification, Utilities Commissioning, Process Equipment Startup, FAT/SAT, IQ/OQ/PQ, Validation, Project Management, Pharmaceutical Facilities, Risk Assessment, Documentation & Handover.