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Job Title: Maintenance Mechanic
Location: Tampa, FL – 33634
Duration: 11 Months
Job Type: Contract
Work Type: Onsite
Pay Rate: $35 to $40 per hour (Negotiable)
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Summary
- 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.
- This individual reviews: equipment and room designs, 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.
Responsibilities
- 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
- 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 the company 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
Required Skills
- 5 years of hands on experience is required
- Maintenance in GMP-regulated environments is required
- Experience in equipment maintenance & repair, both planned and unplanned is required
- Experience in Installation & retrofit support – Including commissioning and decommissioning
- Flexibility to support shift coverage, weekend work, or emergency response when needed.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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