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Senior Commissioning and Qualification Engineer

S4 Analytics Llc — United States · Posted ~3 days ago

Senior

Skills

Commissioning Qualification Sterile Fill-Finish Validation IQ/OQ/PQ GMP Troubleshooting HVAC WFI Steam

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Summary

Seeking an experienced engineering professional to lead commissioning and qualification activities for sterile manufacturing equipment, utilities, and facilities while delivering validation documentation and startup support.

Highlights

Hands-on role supporting commissioning, validation, troubleshooting, and qualification of regulated manufacturing systems and utilities.

Description

Job Title: Sr. Commissioning & Qualification (C&Q) Engineer Location: United States Key Responsibilities: Commissioning, installation, SAT, and qualification of sterile fill-finish equipment.Support startup, troubleshooting, and operational readiness.Qualify prefilled syringe lines, isolators, autoclaves, cleanrooms (Grade C & D), warehouse, cold storage, and GMP utilities (HVAC, WFI, Steam, Nitrogen, Pure Air, Chilled Water).Develop and execute validation documentation (VMP, IQ/OQ/PQ, Validation Summary Reports).Manage deviations and support equipment, utility, and facility qualification activities. Requirements: Strong experience in aseptic sterile fill-finish manufacturing.Hands-on C&Q experience with equipment, utilities, and facilities.Experience writing/executing validation documents and managing deviations.Strong troubleshooting and problem-solving skills.Looking for hands-on professionals with utility and/or equipment qualification experience.