Facilities Specialist

Key Responsibilities

• 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