Job Description
Purpose of the Role
Provide subject matter expertise in establishing, improving, troubleshooting, and executing maintenance and calibration activities. Ensure all assets required for GMP manufacturing and testing of advanced therapeutic products are available, compliant, and fit for use according to operational needs.
Key Responsibilities
Technical Leadership & SME Activities
* Act as the subject matter expert for Calibration, Metrology, and Planned Maintenance methodologies within a GMP environment.
* Define optimal maintenance and calibration strategies for GMP-critical equipment, based on technical understanding and regulatory expectations.
* Provide oversight and approval of calibration and maintenance documentation (internal and vendor-generated) throughout the equipment lifecycle.
Execution & Coordination
1. Coordinate and supervise maintenance and calibration activities performed by both internal teams and external service providers, aligned with the site’s CMMS.
2. Lead creation, review, and approval of calibration and maintenance documentation for new equipment introduction and ongoing lifecycle management.
3. Provide technical input for establishing or revising service agreements with third-party maintenance and calibration suppl...