Process Mechanic – Sterile Filling & Packaging

• Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.
• Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.
• Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.
• Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.
• Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.
• Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).
• Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.
• Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.
• Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.
• Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.

• 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 in a pharmaceutical, biotech, or sterile manufacturing environment.
• Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.
• Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.
• Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.
• Working knowledge of cGMP, aseptic techniques, 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.

• Hands-on role in a cleanroom-based 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.

WhiteCrow Research