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You will be updated with latest job alerts via emailThe 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.
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 crossfunctionally 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 *** 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 24hour 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
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Contract