Maintenance Mechanic

Responsibilities:

• Performs planned and unplanned maintenance on assets in a GMP environment and ensures activities are properly documented.
• Troubleshoot equipment and system failures and determines or supports determination of root cause and recommends/performs corrective actions and preventative measures.
• Manages and issues equipment tooling, ensuring that tools are maintained properly, tracked, kitted for use, and available.
• Coordinates and performs equipment relocation ensuring no damage is incurred during the move and that asset is fully functional and within specification before releasing asset for use.
• Supports installation of new equipment which may include FAT, SAT, execution of qualification protocols, and determination of maintenance plans and spare parts
• Work cross-functionally with other resources (operations, purchasing, planning, QA, Project Management, laboratory, manufacturing, etc.) to schedule, perform and properly document any and all relevant tasks pertaining to GMP Assets.
• Utilizes and develops task lists and maintenance plans derived from experience, asset manuals, and review with manufacturer technical support regarding equipment commissioning, setup, operation, maintenance, and decommissioning.
• Develops and performs; work orders, work permits, change controls, and writes, reviews and/or approves Standard Operating Procedures (SOPs), specifications, and other procedures as required.
• Training of personnel regarding equipment maintenance, setup, operation, cleaning, SOPs, etc.
• Follow Lonza safety guidelines and participate in safety processes and meetings as applicable.
• Provide input for forecasting of budget requirements and help to manage department expenses
• Maintain a positive, professional, and confidential relationship with internal customers, clients, and vendors.
• Comply with all state and federal regulatory requirements and guidelines.
  Provide 24-hour emergency support as defined and perform other applicable duties as assigned.
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
• Stop work where deemed necessary to maintain safety

Education & Experience

• High school diploma or equivalent required.
• Technical certification, associate's degree, or vocational training in mechanical, electrical, mechatronics, or related field preferred.
• Minimum 5 years' experience in GMP maintenance, equipment mechanics, or similar technical role in a regulated industry (pharma, biotech, or manufacturing).
• Additional training in safety, compliance, or maintenance systems (CMMS/Maximo/SAP) is a plus.