Leading blended teams of employees and contingent workers
This role leads a team responsible for preparing compliant, inspection-ready documentation to support Engineering projects and GMP manufacturing operations
Job Summary
This role leads a team responsible for preparing compliant, inspection-ready documentation to support Engineering projects and GMP manufacturing operations.
The position requires overseeing the development of protocols, reports, risk assessments, and traceability matrices using established Center of Excellence standards.
Candidates must partner with cross-functional teams including Validation, Quality, and Manufacturing to ensure operational readiness and consistent documentation quality.
Matching Summary
This role leads a team responsible for preparing compliant, inspection-ready documentation to support Engineering projects and GMP manufacturing operations.
Skills & Requirements
Must-have
GMP commissioning and qualification experience
C&Q documentation protocol and report preparation
Leading blended teams of employees and contingent workers
Risk-based qualification methodologies knowledge
Inspection readiness and data integrity principles
Nice-to-have
Continuous improvement initiative contribution
Strong project management and organizational skills
Excellent written and verbal communication abilities
Experience with packaging equipment or facilities utilities
Collaboration across multiple engineering departments
Key Requirements
8-13 years of work experience in relevant field
Bachelor's or Master's degree required
Experience in regulated pharmaceutical or biotechnology environment