Position Summary
The GMP Asset Mechanic is responsible for ensuring GMP production assets are properly evaluated, qualified, maintained, commissioned, decommissioned, and documented throughout their lifecycle. This role involves reviewing equipment and room designs, executing maintenance and qualification tasks, troubleshooting failures, and supporting process improvements with preventative actions. The individual will also supervise external contractors and manage spare parts procurement and documentation.
Key Responsibilities
- Perform planned and unplanned maintenance on GMP assets with proper documentation.
- Troubleshoot equipment/system failures, determine root causes, and implement corrective/preventative actions.
- Manage and issue equipment tooling — maintain, track, and prepare tools for use.
- Coordinate and execute equipment relocation, ensuring no damage and functionality verification post-move.
- Support new equipment installation, including FAT, SAT, qualification protocol execution, and maintenance/spare part planning.
- Collaborate cross-functionally (Operations, QA, Planning, Project Management, etc.) to schedule and perform GMP asset tasks.
- Develop and utilize task lists and maintenance plans based on experience, manuals, and manufacturer support.
- Create and execute work orders, work permits, change controls, and review/approve SOPs, specifications, and procedures.
- Train personnel on equipment maintenance, setup, operation, cleaning, and related SOPs.
- Follow safety guidelines and participate in safety processes and meetings.
- Provide input for budget forecasting and help manage departmental expenses.
- Maintain professional and confidential relationships with internal stakeholders and vendors.
- Ensure compliance with all applicable federal and state regulations.
- Provide 24-hour emergency support as needed and perform other duties as assigned.
- Adhere to all safety and sustainability requirements, reporting issues or opportunities for improvement immediately.
- Stop work if necessary to ensure safety compliance.
Qualifications
- Minimum 5 years of experience in maintenance or mechanical roles within a GMP-regulated environment.
- Strong understanding of GMP standards, equipment qualification, and documentation requirements.
- Experience with equipment commissioning, preventative maintenance, and root cause analysis.
- Excellent troubleshooting skills and familiarity with asset management practices.
- Strong communication and collaboration skills across multidisciplinary teams.
- Ability to train others and manage contractors.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Management and Manufacturing
- Industries: IT Services and IT Consulting