Calibration & Maintenance Engineer

Job description

Your mission Provide subject matter expertise in the establishment, improvement, troubleshooting and execution of maintenance and calibration activities, to ensure that assets required for the GMP manufacture and testing of gene therapy products are available and fit for use in line with business requirements. Job Description: Major Activities: - SME for Calibration, Metrology and Planned Maintenance techniques and requirements. - Responsible for defining the optimum approach for maintenance and calibration of GMP assets, based on technical knowledge and cGMP requirements/best practice. - Responsible for coordinating technical oversight and approval of calibration and maintenance technical documentation (internal and external) throughout the equipment lifecycle. - Responsible for the coordination and supervision of maintenance and calibration activities by internal and external resources in accordance with the CMMS. - Responsible for creation, review and approval of maintenance and calibration technical documents for new equipment introduction and throughout the equipment lifecycle - Responsible for technical input into new/revised Service Level Agreements with 3rd parties for cali...