Calibration & Maintenance Engineer

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 3^rd 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 MeiraGTx 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

• 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 operation, administration and development of Computerised Maintenance Management Systems including developing workflows, job plans, calibration management systems.
• HNC / HND / Degree level education in relevant Engineering discipline.
• Excellent standard of written and verbal communication in English language.