Job Description
If you want to know about the requirements for this role, read on for all the relevant information.
The Calibration and Maintenance Engineer will 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.
The Major Activities of the Calibration and Maintenance Engineer is a follows
- 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 calibration and maintenance
- Responsible for authoring and maintaining Technical Standards relating to calibration and maintenance, in partnership with other Calibration & Maintenance Engineers
- Responsible for demonstrating a high standard of health and safety behaviour and practice, ensuring that all EHS commitments are delivered on time in full
- Responsible for supporting a state of Inspection Readiness every day within the Facilities and Maintenance Engineering team, and for supporting the successful prepration and fronting of Regulatory Inspections and Audits
- Manage Quality processes including Risk Assessments, Change Controls, CAPAs and Deviations as per the site Quality Management System, including as lead for deviations relating to maintenance as-found failures.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation assigned e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state that comply with company procedures including Health and safety and GMP
- Responsible for identifying, collaborating and delivering continuous improvements within the Facilities & Maintenance team to improve safety, quality, service and cost
Key Performance Indicators xwzovoh
- Planned Preventative Maintenance and Calibration timeliness
- Timely response to unplanned maintenance requirements
- Timely completion of all Safety and Quality commitments
Key Job Competencies
- Subject Matter Expertise in Calibration, Maintenance and/or Metrology
Job Responsibilities
- Supervision of internal and external personnel performing planned maintenance
- Responsible for approving master documentation and executed documentation as SME
- Responsible to front as SME in regulatory inspections regarding Calibration and Maintenance
Job Background
- Experience performing and/or supervising maintenance in GMP operational facilities
- Experience with Computerised Maintenance Management Systems
- HNC / HND / Degree level education in relevant Engineering discipline
- Excellent standard of written and verbal communication in English language