GMP Facility Engineer

Merck•Saint Louis, MO

12d•Onsite

About The Position

The GMP Facilities Engineer at MilliporeSigma in St. Louis, MO is a critical engineering role operating within the GMP Maintenance & Engineering team who serves as a subject matter expert on utilities supporting cGMP API manufacturing. Utilities include but are not limited to pure water up to USP Water for Injection quality, clean steam, clean compressed air and other process gases, cleanroom HVAC systems, electrical systems, and control systems supporting monitoring of such utilities.

Requirements

Bachelor’s Degree in Chemical Engineering, Mechanical Engineering or other engineering discipline.
4+ years of plant engineering experience.

Nice To Haves

Experience with chemical and pharmaceutical maintenance and/or project management experience in a cGMP regulated environment.
Experience with chemical, pharmaceutical or CGMP engineering.
Knowledge of Process Safety Management.
Experience with Emerson DeltaV or other DCS and Rockwell/Allen-Bradley PLCs, Experience with other process automation equipment such as VFDs, instrumentation, and discrete control devices.
Experience with Building Automation Systems such as Siemens Apogee.
Knowledge of applicable IBC, NEC, NFPA, USP, and other relevant engineering and construction codes and standards.
Experience with reading, understanding, and maintaining site drawings, including utility and facility plan drawings, P&IDs, electrical one-lines, and controls diagrams.

Responsibilities

Manage all utility activities, including operation, preventative maintenance, risk assessments, troubleshooting, and Root Cause Analysis (RCA) to prevent reoccurrences.
Prioritize and manage planned and unplanned work to minimize equipment downtime and prevent disruptions to the manufacturing schedule.
Lead small-scale projects and provide technical oversight for major utility upgrades or expansions, ensuring all designs meet IBC, NEC, NFPA, and USP codes.
Oversee User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), commissioning, and validation activities for new and improved systems.
Serve as the Subject Matter Expert (SME) for utility systems during regulatory audits and ensure strict adherence to GMP Quality Management Systems.
Develop and maintain site specifications, standard operating procedures (SOPs), and statements of work to facilitate consistent facility operations.
Generate and execute change controls, lead deviation investigations, and implement effective Corrective and Preventive Actions (CAPA).
Coordinate with Maintenance, Quality, and Manufacturing teams to identify operational gaps and provide technical training on new or upgraded systems.