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