Responsibilities:
- 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.
Requirements:
- 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 associates 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract