Facility Mechanic

The Facility Mechanic is a skilled and safety-focused, hands-on technician supporting the installation, operation, and maintenance of utility and facility equipment used to support production of sterile IV bagsat our new, state-of-the-art pharmaceutical manufacturing facility. As part of a startup team, this individual will play a critical hands-on role in ensuring equipment reliability, robustness, and compliance with cGMPs and safety standards. The ideal candidate has experience in pharmaceutical or cleanroom environments, is experienced working in a regulated environment with equipment following strict change control procedures, is mechanically adept, and takes pride in supporting safe operations of all site utility and facility systems.

Key Responsibilities:

1. Perform preventive and corrective maintenance, troubleshooting and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.
2. Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.
3. Conduct round and inspection to monitor system performance and proactively address issues.
4. Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.
5. Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).
6. Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.
7. Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.
8. Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.
9. Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.
10. Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.

Qualifications:

• High school diploma or technical certificate required; Associate’s degree in a mechanical or technical field preferred.
• 3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.
• Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.
• Strong troubleshooting skills for mechanical, electrical, and control system issues.
• Familiarity with building management systems (BMS) and alarm monitoring systems.
• Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.
• Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).
• Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.
• Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).
• Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.
• Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.

Work Environment:

• Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.
• Requires frequent gowning, standing, and work in confined or classified areas.
• Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.
• Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.
• Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools.