Follow all applicable quality systems, policies, and procedures to ensure products meet safety, quality, and regulatory standards
Perform maintenance, troubleshooting, and repair on production equipment, laboratory systems, and facility infrastructure
Diagnose and resolve issues related to mechanical, electrical, pneumatic, and control systems, including motors, pumps, HVAC, vacuum systems, and process utilities
Support maintenance and repair of specialized manufacturing equipment such as isolator systems, filling/packaging lines, and associated utilities
Read and interpret technical documentation including P&IDs, wiring diagrams, system layouts, and equipment specifications
Support continuous operations in a 24/7 manufacturing environment following site startup
Develop, revise, and maintain SOPs, work instructions, and maintenance documentation
Perform calibration and ensure functionality of monitoring and detection equipment as required
Accurately document maintenance activities, work orders, and asset history within a CMMS
Assist in spare parts identification and inventory support
Provide responsive technical support to internal stakeholders with a focus on minimizing downtime
Participate in equipment startup, commissioning, and qualification activities
Support investigations, deviations, and CAPAs from a maintenance/engineering perspective
Execute preventative and corrective maintenance within controlled or cleanroom environments
Ensure all documentation is completed in compliance with cGMP standards
Train and mentor junior technicians as needed
Perform additional duties as assigned
Qualifications & Requirements
High school diploma or equivalent required; associate or bachelor’s degree preferred
Minimum 3+ years of hands-on maintenance experience in a regulated manufacturing environment (GMP strongly preferred)
Experience supporting aseptic processing, fill/finish operations, or highly controlled production environments is a plus
Background in pharmaceutical, biotech, or medical device industries preferred
Familiarity working in environments involving hazardous or controlled materials is a plus
Strong understanding of regulatory and safety standards (e.g., OSHA, FDA, etc.)
Effective communication, teamwork, and organizational skills
Proficiency with Microsoft Office, CMMS platforms, and building management systems
Ability to lift up to 50 lbs and perform physical tasks such as climbing ladders
Willingness to work in controlled environments requiring PPE, including cleanrooms and confined spaces
Flexibility to work off-shift hours, weekends, or holidays as required
