Pharmaceutical Maintenance Technician

2 weeks ago

Indianapolis IN, United States VALIDATION ASSOCIATES LLC Full time

Summary: 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. Do not wait to apply after reading this description a high application volume is expected for this opportunity. 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. xrczosw Must haves: GNP maintenance experience (3 years minimum exp) Pharma experience (4- 5 years) Significant years experience in process systems Parallel to regulatory requring food & beverage or Healthcare related Pharma 4-5 yrs of experience Flexibility with Schedules Work schedule would likely start as a standard work schedule (M-F days) and then would move to a shift schedule. Would move to shift schedule as of March 2026: • Mon – Thur Nights (1900-0500) – 10 hr shift • Fri – Sun Days ( – 12 hr shift • Fri – Sun Nights (1900-0700) – 12 hr shift

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