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.
Job Title: Maintenance Mechanic
Location: Tampa FL 33634
Duration: 11 Months
Job Type: Temporary Assignment
Work Type: Onsite
Summary
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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.
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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.
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The individual recommends and/or procures spare parts and consumables.
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Individual will provide supervision of external contractors to maintain equipment while documenting historically significant activities as directed.
Responsibilities:
- Perform both planned and unplanned maintenance on GMP production assets ensuring proper documentation of all activities.
- Troubleshoot equipment and system failures determine root causes and implement corrective and preventive actions.
- Manage and issue equipment tooling ensuring tools are properly maintained tracked and available for use.
- Coordinate equipment relocations ensuring assets are functional and within specifications before being released for use.
- Support installation of new equipment including FAT SAT execution of qualification protocols and maintenance planning.
- Collaborate cross-functionally with operations purchasing planning QA project management and other departments to ensure proper scheduling and documentation of GMP-related tasks.
- Develop and review maintenance plans task lists and documentation in collaboration with manufacturers and technical support teams.
- Draft review and approve Standard Operating Procedures (SOPs) work orders work permits and change controls.
- Train personnel on equipment maintenance setup operation cleaning and safety protocols.
- Adhere to safety guidelines and participate in safety processes and meetings.
- Assist with budget forecasting and manage department expenses.
- Ensure compliance with all regulatory requirements and industry standards.
- Provide 24-hour emergency support and perform additional duties as assigned.
- Report and address any identified safety sustainability and operational issues promptly.
Required Skills:
- 5 years of experience in a GMP environment specifically in asset maintenance or mechanical roles.
- Strong troubleshooting and problem-solving skills with the ability to determine root causes of equipment failures.
- Experience in the qualification installation and commissioning of production assets including FAT/SAT and protocol execution.
- Knowledge of GMP regulations industry standards and documentation requirements.
- Ability to develop and implement maintenance plans work orders SOPs and other documentation.
- Strong organizational skills and ability to manage multiple tasks and projects simultaneously.
- Experience working cross-functionally with various departments (operations QA project management etc.).
- Proficiency in using asset management systems and Microsoft Office Suite.
- Strong attention to detail and ability to ensure compliance with all safety and regulatory guidelines.
- Ability to work independently and as part of a team in a fast-paced dynamic environment.
- Experience in training personnel on equipment maintenance and safety protocols.
Preferred Skills:
- Experience with preventive and corrective maintenance strategies in a manufacturing or production environment.
- Experience working with equipment relocation and ensuring assets are fully functional post-move.
- Familiarity with client safety guidelines and industry-specific safety processes.
- Previous experience with budget forecasting and expense management.
- Certification or training in GMP mechanical maintenance or related fields.
- Experience with external contractor supervision and vendor management.
- Knowledge of state and federal regulatory requirements in a manufacturing or GMP setting.
- Experience in Sustainability and Safety programs and reporting safety-related issues.
TekWissen Group is an equal opportunity employer supporting workforce diversity.