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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