Maintenance Technician

Role Purpose:

• An exciting new opportunity has arisen for a Maintenance Technician at our client’s biopharmaceutical facility in Co. Waterford.
• As a Maintenance Technician, you’ll play an important role in being a maintenance subject matter expert in all systems associated with the Sterile Fill Finish Operation. You will also have responsibilities to maintain equipment/systems in non-GMP areas that are critical to the manufacturing process.
• Please note this is a shift position (days – 7am to 3pm and evenings – 3pm to 11pm shift with 2 long days and nights (12 hours) on rotation. No weekends (with some exceptions).
• The role will also be required to support an on-call roster (7days – one out of six weeks in rotation).

Core Duties and Responsibilities:

• Support the Operations Team through troubleshooting process equipment problems to ensure reliable operation of the plant.
• Ensuring all routine maintenance work (PM, PdM & Cal’s) 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 are in compliance with GMP regulations
• Compliance to 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.

Health, Safety and the Environment

• 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.

Quality Compliance

• 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

Education & Qualifications Required:

• Fully qualified to National Craft Standard or equivalent 3rd Level Qualification
• Minimum 2 years’ maintenance experience in the Biopharmaceutical industry or similar cGMP manufacturing experience (API, OSD, Med Device, Infant Formula, etc.)
• Multi-skilled – Primarily Electrical with an understanding of Calibration and Instrumentation. Basic mechanical knowledge would be an advantage also.
• Desirable equipment experience: Vial / PFS Fill Line, Isolator, CLU, Autoclave, Parts Washer, Inspection Machine, Lyophiliser, HVAC, WFI / PUW, Process Air / Nitrogen, Safety &Electrical (MV / LV) Systems.
• Experience with problem-solving skills, troubleshooting, and setup of process equipment.
• Ability to interpret P&IDs, equipment/system layouts, wiring & pneumatic diagrams, etc.
• Must be knowledgeable of the GMP regulatory requirements for maintenance activities.
• Proficient in the use of CMMS, experience in PEMAC, MAXIMO or SAP PM preferable.
• Operate and retrieve/interpret data from control systems (SCADA, QBMS, BMS).
• Audit experience providing technical assurance, (FDA, HPRA, EPA, etc) advantageous.
• Experience in drafting SOPs, WIs and PMs would be an advantage.
• Proficient in the use of Microsoft Office and other computer applications.
• Excellent interpersonal, written and verbal communication skills.
• Strong Attitude to learn and develop
• Continuous Improvement Project/initiatives
• Shift and On call required

Please note, we do not require agency assistance with this role.