Engineering - R&D - Process Development Engineer

Process Maintenance Technician

The Process Maintenance Technician plays a critical role in ensuring the reliability and performance of production and support equipment in a regulated pharmaceutical manufacturing environment. This role involves executing reactive, preventive, and predictive maintenance, troubleshooting mechanical, hydraulic, pneumatic, and control systems, and supporting GMP-compliant operations. The technician may work one of various shift patterns, including 8, 10, or 12 hours, occurring on days or nights, weekdays or weekends, and be 100% on-site at the client facility.

Key Responsibilities:

• Perform maintenance activities in compliance with cGMPs and SOPs.
• Assemble, disassemble, install, repair, and replace components for pharmaceutical-grade machinery and cleanroom equipment.
• Troubleshoot and resolve issues in mechanical, electrical, pneumatic, and PLC-controlled systems.
• Maintain accurate documentation including Maintenance and Calibration Records per cGMP standards.
• Inspect equipment for wear, irregularities, and potential failures.
• Collaborate with cross-functional teams (Quality, Engineering, Production) to ensure equipment reliability and compliance.
• Execute scheduled PMs and CMMS updates in a timely and accurate manner.
• Maintain tools and workspaces in accordance with cGMP housekeeping standards.
• Adhere to OSHA, and site-specific safety protocols.
• Participate in continuous improvement initiatives and equipment reliability programs.
• Support audits and inspections by regulatory bodies and internal quality teams.
• Other duties as assigned.

Metrics for Success:

• PM completion rate and CMMS accuracy
• Equipment uptime and reliability
• Compliance with GMP documentation standards
• Audit readiness and deviation reduction
• Responsiveness to unplanned maintenance events

Experience Required:

• Minimum 3-5+ years of experience in mechanical maintenance within pharmaceutical, biotech, or regulated manufacturing environments.
• Strong mechanical aptitude with troubleshooting and critical thinking skills.
• Familiarity with demands of performing maintenance activities in a cGMP environment.
• Ability to interpret technical documentation and engineering drawings.
• Strong communication, organizational, and analytical skills.
• Comfortable working in confined spaces, heights, and around chemicals.
• Ability to use basic hand tools, power tools and meters (DVM, Amp and Ohm).

Other Preferred:

• Certification in First Aid or CPR
• Familiarity with ISO standards and FDA audit processes.
• Experience supporting equipment qualification (IQ/OQ/PQ).
• Experience with aseptic processing, HVAC systems, and utility maintenance is a plus.
• Technical diploma or degree in Mechanical Engineering or equivalent.
• Proficiency in troubleshooting PLCs, HMIs, and automated systems.
• Skilled in using lathes, mills, grinders, and precision instruments.

Must haves:

• GNP maintenance experience (3 years minimum exp)
• Pharma experience (4 - 5 years)
• Significant years experience in process systems parallel to regulatory requiring food & beverage or Healthcare related Pharma 4-5 yrs of experience
• Flexibility with schedules