We are seeking an experienced Facilities Engineer to support the maintenance, troubleshooting, repair, and optimization of manufacturing equipment and facility systems within a GMP-regulated environment in Waltham, MA.
This position is responsible for ensuring the safe, reliable, and efficient operation of production equipment and critical facility systems. The ideal candidate will possess strong mechanical, electrical, and electromechanical troubleshooting skills, along with hands‑on experience in preventive maintenance, equipment qualification, and continuous improvement.
The Facilities Engineer will collaborate with cross‑functional teams, oversee external contractors, lead equipment improvement projects, and ensure maintenance activities align with manufacturing schedules, safety standards, and regulatory requirements.
Key Responsibilities
Equipment Maintenance & Troubleshooting
- Diagnose, troubleshoot, repair, and maintain manufacturing equipment and facility systems to ensure safe and reliable operation.
- Perform routine equipment inspections and facility rounds to identify potential failures, inefficiencies, or maintenance needs.
- Conduct equipment start‑ups, changeovers, adjustments, and preventive maintenance activities.
- Troubleshoot mechanical, electrical, pneumatic, hydraulic, plumbing, and electromechanical systems.
- Provide technical support for electrical controls, drives, motors, gearboxes, and AC/DC control systems.
- Support equipment calibrations, system upgrades, and performance optimization initiatives.
- Identify equipment downtime issues, communicate impacts to stakeholders, and coordinate timely resolution.
Facilities Engineering & Project Support
- Provide technical ownership and subject matter expertise for manufacturing equipment, critical facility systems, and spare parts assessments.
- Lead and coordinate maintenance projects, equipment repairs, and system improvements while minimizing production disruptions.
- Oversee external vendors and contractors performing maintenance, repairs, installations, and equipment servicing.
- Support planned facility shutdowns, equipment upgrades, and commissioning activities.
- Develop, update, and maintain engineering drawings, equipment documentation, and technical procedures.
- Evaluate equipment performance and recommend modifications to improve reliability, efficiency, and operational sustainability.
GMP Compliance & Documentation
- Ensure all maintenance and engineering activities comply with GMP/GxP requirements, safety regulations, and established procedures.
- Draft, review, and execute equipment qualification protocols, Standard Operating Procedures (SOPs), and work instructions.
- Support the development and improvement of preventive maintenance, calibration, and equipment operating procedures.
- Participate in quality audits, deviation investigations, CAPAs, and GMP‑related investigations.
- Maintain accurate documentation of maintenance activities, equipment performance, and corrective actions.
- Ensure compliance with applicable electrical safety standards, including the National Electrical Code (NEC) and NFPA 70E.
Continuous Improvement & Collaboration
- Partner with Manufacturing, Quality, Engineering, and Facilities teams to resolve technical issues and support operational objectives.
- Identify opportunities to improve equipment reliability, reduce downtime, and enhance maintenance processes.
- Apply Lean Manufacturing and 5S/6S principles to improve efficiency and workplace organization.
- Prioritize maintenance activities based on operational needs and production schedules.
- Maintain a safe, clean, and organized working environment.
- Perform additional engineering and facilities‑related responsibilities as assigned.
Required Qualifications
- Minimum 3 years of hands‑on experience in advanced electrical, mechanical, electromechanical, or manufacturing equipment maintenance and repair.
- GMP experience is required, preferably within pharmaceutical, biotechnology, life sciences, or medical device manufacturing.
- Strong mechanical and electrical aptitude with demonstrated troubleshooting experience.
- Experience maintaining and repairing industrial manufacturing equipment, including automated production or packaging systems.
- Working knowledge of electrical controls, motors, drives, and AC/DC control systems.
- Experience troubleshooting pneumatic, hydraulic, and mechanically controlled equipment.
- Ability to evaluate equipment performance, identify root causes of failures, and implement effective solutions.
- Ability to read and interpret technical drawings, schematics, and Piping and Instrumentation Diagrams (P&IDs).
- Familiarity with the National Electrical Code (NEC) and NFPA 70E electrical safety standards.
- Proficiency with Microsoft Word and Excel; familiarity with Microsoft Project.
- Strong organizational, communication, and problem‑solving skills.
- Ability to independently prioritize multiple assignments and respond effectively to urgent maintenance needs.
Preferred Qualifications
- Degree in Engineering or a related technical discipline, completion of a recognized trade apprenticeship, or equivalent combination of technical training and experience.
- Electrical, Plumbing, HVAC, or PLC‑related licensure or certifications.
- Extensive facilities or manufacturing equipment experience within the life sciences or medical device industry.
- Experience with Programmable Logic Controllers (PLCs) and electronically controlled manufacturing systems.
- Experience with angle drive motors, gearbox systems, and industrial equipment upgrades.
- Familiarity with CAD software, including SolidWorks.
- Experience developing or executing equipment qualification protocols.
- Knowledge of preventive maintenance programs, calibration systems, and GMP documentation practices.
- Experience with Lean Manufacturing, 5S/6S, and continuous improvement initiatives.
- Previous project leadership, vendor management, or supervisory experience.
Physical Requirements
- Ability to regularly stand, walk, and use hands to operate tools and equipment.
- Ability to frequently sit, reach, stoop, kneel, crouch, or crawl as required.
- Ability to lift and/or move up to 50 pounds.
- Adequate peripheral vision and depth perception to safely perform technical duties.
- Ability to work in manufacturing and facilities environments while following all applicable safety procedures.