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Automation Technician

Nivagen Pharmaceuticals, Inc.

Role Summary The Automation Technician is responsible for installation, calibration, maintenance, and troubleshooting of automation systems, process instrumentation, control components, and sterile manufacturing equipment. The role ensures accurate measurement, reliable system performance, and continuous operation of clean utilities, aseptic processes, and production systems in compliance with cGMP, FDA 21 CFR Part 11, and cleanroom standards. Responsibilities and Skill Set Requirements Install, maintain, and troubleshoot process instruments including pressure, temperature, flow, level, pH, conductivity, environmental monitoring sensors, motors, pumps, fans, drives, control valves, actuators, circuits, drives, junction/termination boxes, instrument & control cabinets, automated systems control components and sterile production equipment. Perform conduit bending, cable routing, tray installation, wire pulling, cable termination, and equipment connections as per plant procedures, loop checks, functional testing, system commissioning, FAT/SAT, preventive, predictive, and corrective maintenance activities to ensure equipment reliability. Maintain accurate CMMS records, calibration logs, maintenance reports, and audit-ready documentation. Interpret P&IDs, wiring diagrams, loop drawings, schematics, and ladder logic. Use diagnostic tools such as multi-meters, clamp meters, insulation testers, loop calibrators, and other testing equipment. Support in performing GMP-compliant calibration activities and validation activities (IQ/OQ/PQ) with full traceability, accuracy verification, and proper documentation and maintaining cleanroom support systems. Support relevant systems associated with utilities such as PW, WFI, Clean Steam, CIP/SIP, HVAC/HEPA control, and process equipment such as Pass boxes, LAF, Autoclaves, filtration/formulation vessels, isolators, sterile filling & capping machines, packaging systems, warehouse etc. Ensure compliance with cGMP, FDA 21 CFR Part 11, ISO cleanroom standards, validation requirements, and data integrity practices. Industrial Working Conditions Ability to work rotating shifts, weekends, and extended hours as required by production schedules. Exposure to high-noise environments (hearing protection provided). Frequent work on mezzanine floors, elevated platforms, ladders, and step ups. Work in aseptic cleanrooms (ISO 5/7/8) requiring full gowning and adherence to strict protocols. Exposure to pressurized, hot, cold, and humid systems (PW, WFI, Clean Steam, HVAC). Work in confined spaces, equipment enclosures & behind panels required. Regular use of PPE, including sterile gowning and safety equipment. Ability to lift up to 50 lbs and perform physical, hands‑on technical tasks for extended durations. Experience 5–7 years of experience in pharmaceutical, biotech, or FDA regulated process manufacturing preferred. #J-18808-Ljbffr Nivagen Pharmaceuticals, Inc.

Vacancy posted 1 day ago
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