Lead the preparation and delivery of commissioning and qualification documentation supporting Engineering project execution and GMP manufacturing systems
Job Summary
Lead the preparation and delivery of commissioning and qualification documentation supporting Engineering project execution and GMP manufacturing systems.
Manage a blended team of employees and contingent workers to ensure compliant, inspection-ready documentation for successful C&Q and operational readiness.
Partner with cross-functional teams including Engineering, Validation, Quality, and Manufacturing to ensure documentation quality and alignment with project timelines.
Matching Summary
Lead the preparation and delivery of commissioning and qualification documentation supporting Engineering project execution and GMP manufacturing systems.
Skills & Requirements
Must-have
C&Q documentation preparation
GMP manufacturing systems
Regulatory inspections support
Risk-based qualification methodologies
Nice-to-have
Leadership and coaching
Continuous improvement initiatives
Collaboration across teams
Key Requirements
8-13 Years of work experience
Bachelors or Masters degree
Experience in GMP commissioning, qualification, validation, or technical operations