Calibration and Maintenance Engineer
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 followsSME for Calibration, Metrology and Planned Maintenance techniques and requirementsResponsible for defining the optimum approach for maintenance and calibration of GMP assets, based on technical knowledge and cGMP requirements/best practiceResponsible for coordinating technical oversight and approval of calibration and maintenance technical documentation (internal and external) throughout the equipment lifecycleResponsible 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 lifecycleResponsible for technical input into new/revised Service Level Agreements with 3rd parties for calibration and maintenanceResponsible for authoring and maintaining Technical Standards relating to calibration and maintenance, in partnership with other Calibration & Maintenance EngineersResponsible for demonstrating a high standard of health and safety behaviour and practice, ensuring that all EHS commitments are delivered on time in fullResponsible 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 AuditsManage 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 proceduresResponsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertakenResponsible 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 GMPResponsible for identifying, collaborating and delivering continuous improvements within the Facilities & Maintenance team to improve safety, quality, service and costKey Performance IndicatorsPlanned Preventative Maintenance and Calibration timelinessTimely response to unplanned maintenance requirementsTimely completion of all Safety and Quality commitmentsKey Job CompetenciesSubject Matter Expertise in Calibration, Maintenance and/or MetrologyJob ResponsibilitiesSupervision of internal and external personnel performing planned maintenanceResponsible for approving master documentation and executed documentation as SMEResponsible to front as SME in regulatory inspections regarding Calibration and MaintenanceJob BackgroundExperience performing and/or supervising maintenance in GMP operational facilitiesExperience with Computerised Maintenance Management SystemsHNC / HND / Degree level education in relevant Engineering disciplineExcellent standard of written and verbal communication in English language
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