Maintenance Mechanic (GMP Asset Mechanic)

Job Title: Maintenance Mechanic (GMP Asset Mechanic)

Duration: 12 Months (Possible Extension or Conversion)

Location: Tampa, FL 33634

Onsite position

Job Description:

The GMP Asset Mechanic is responsible to ensure that GMP production assets are evaluated prior to purchase, qualified and documented as needed, maintained and commissioned prior to use, and properly decommissioned and stored for future use. These individual reviews: equipment and room design, executes qualification and maintenance activities, troubleshoots and assesses failures and corrective work as well as implement applicable preventative actions, and provides input for the development of maintenance plans, tasks, procedures, and schedules. The individual recommends and/or procures spare parts and consumables. Individual will provide supervision of external contractors to maintain equipment while documenting historically significant activities as directed.

Key Accountabilities

• 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 client 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
• 5 years' experience

Additional Details:

• The GMP Asset Mechanic role is divided into three levels, based on increasing accountability and technical proficiency. All levels support safe and reliable operation of oral dosage manufacturing equipment.

Essential Job Functions

• Participate in equipment changeover and setup as required
• Maintain inventory of necessary spare parts to minimize equipment downtime
• Research, request, and procure components and equipment as needed
• Perform maintenance activities safely, efficiently, and in compliance with GMP standards
• Complete all required documentation (work orders, logbooks, cGMP forms) accurately and on time
• Assist in equipment installation and retrofit projects, including qualification activities
• Support equipment troubleshooting with engineers, operators, and vendors
• Collaborate with cross-functional teams (QA, EHS, Operations, Engineering) to resolve technical issues
• Participate in continuous improvement efforts related to equipment uptime and reliability
• Ensure compliance governmental regulations, policies, and procedures
• Track and support maintenance metrics (e.g., PM completion rate, downtime)
• Provide hands-on support to manufacturing and technical teams as needed
• Assume temporary leadership responsibilities in the absence of Maintenance Team Leader
• Participate in internal/external training to support personal development and advancement

Additional Expectations:

• Flexibility to support shift coverage, weekend work, or emergency response when needed