Job Description

• Perform scheduled and unscheduled maintenance on GMP assets and ensure proper documentation of all work performed.
• Troubleshoot equipment and system failures, identify root causes, and implement corrective and preventive actions.
• Coordinate equipment relocation efforts to ensure assets remain undamaged and within specification after moves.
• Support new equipment installation, including Factory and Site Acceptance Testing (FAT/SAT), qualification protocol execution, and maintenance plan development.
• Manage equipment tools and spare parts inventory, ensuring tools are properly maintained, tracked, and readily available.
• Develop and maintain equipment task lists and maintenance plans based on manuals, manufacturer input, and historical data.
• Draft, review, and/or approve SOPs, specifications, change controls, work permits, and other controlled documents.
• Train personnel on equipment operation, maintenance procedures, cleaning, and safety protocols.
• Collaborate cross-functionally with QA, operations, planning, purchasing, and other departments to execute GMP asset tasks.
• Provide emergency on-call support as required, including participation in a 24-hour support rotation.
• Ensure compliance with all safety, sustainability, and regulatory standards. Promptly report and address safety issues.
• Support budgeting and expense tracking for maintenance and spare parts procurement.

• Minimum of 5 years' experience in a GMP-regulated environment performing equipment maintenance or technical support.
• Proven experience with equipment qualification, commissioning, and decommissioning.
• Strong troubleshooting and root cause analysis skills.
• Familiarity with maintenance management systems (CMMS) and documentation practices in GMP environments.
• Ability to read technical manuals, schematics, and equipment documentation.
• Strong written and verbal communication skills.
• Experience supervising contractors is a plus.
• Must be able to work independently and as part of a cross-functional team.
• Commitment to safety, quality, and continuous improvement.
• Technical certification or associate's degree in a mechanical, electrical, or engineering-related field.
• Experience in pharmaceutical, biotechnology, or other regulated industries.
• Knowledge of FDA, EMA, and/or ISO regulations as they pertain to GMP maintenance.

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