Summary:
Our client, a biopharmaceutical company located in Waterford, is seeking a Maintenance Technician. The successful candidate will act as a subject matter expert for all maintenance systems associated with the Sterile Fill Finish Operation. The incumbent will also be responsible for maintaining equipment and systems in non-GMP areas critical to the manufacturing process. Please note, this is a shift-based position that requires participation in an on-call roster.
Responsibilities: Support the operations team through troubleshooting process equipment problems to ensure reliable operation of the plant. Ensuring all routine maintenance work (PM, PdM & Calibrations) is completed to planning and scheduling requirements. Ensuring that there are minimal or no breakdowns or disruptions in the Production, Utilities or Facilities processes. Keeping a record in the CMMS of all service, maintenance and refurbishing works carried out on the equipment. Supervising outside contractors/vendors to maintain equipment in validated state to support Production and Utilities. Compiling and developing Service Level Agreements for equipment and systems. Monitoring performance of the services provided by service providers to ensure that they perform to company standards. Leading and supporting Continuous Improvement and change within respective areas and systems. Working closely with all customers and support functions to ensure Regulatory Compliance (FDA, HPRA, EPA, etc) and prompt customer service. Ensuring all areas of responsibility comply with GMP regulations. Compliance with all site Environmental, Health and Safety requirements, training and regulations. Ensure critical spare parts requirements are available and cost-effective for equipment. Develop Maintenance SOPs, Work Instructions (WI) and Preventative Maintenance (PM) instructions to ensure all maintenance activities are performed safely, and in accordance with approved procedures. Support Project activities as required to ensure Maintenance and Operational requirements are included. FAT attendance, commissioning and qualification support. Comply at all times with the Health, Safety and Environmental policy and associated procedures. Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do. Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines. Take ownership of quality compliance in all activities you are responsible for Qualifications & Experience: Fully qualified to National Craft Standard or equivalent 3rd Level Qualification. Minimum 2 years of maintenance experience in the biopharmaceutical industry or similar cGMP manufacturing environments (e.g., API, OSD, Medical Device, Infant Formula). Multi-skilled, with a primary focus on Electrical work and an understanding of Calibration and Instrumentation. Basic mechanical knowledge is also an advantage. Desirable experience with equipment such as Vial/PFS Fill Line, Isolators, CLU, Autoclaves, Parts Washers, Inspection Machines, Lyophilisers, HVAC systems, WFI/PUW, Process Air/Nitrogen systems, and Safety & Electrical (MV/LV) Systems. Ability to interpret P&IDs, equipment/system layouts, wiring diagrams, pneumatic diagrams, etc. Strong understanding of GMP regulatory requirements for maintenance activities. Proficient in using CMMS systems; experience with PEMAC, MAXIMO, or SAP PM is preferred. Capable of operating and interpreting data from control systems such as SCADA, QBMS, and BMS. Experience providing technical assurance during audits (e.g., FDA, HPRA, EPA) is advantageous. Experience in drafting SOPs, Work Instructions (WIs), and Preventive Maintenance (PM) procedures is a plus. Proficiency in Microsoft Office and other relevant computer applications.
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