GMP Facility Engineer
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Overview
Job Description
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
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.
Responsibilities include but are not limited to:
- 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.
Who You Are:
Minimum Qualifications:
- Bachelor's Degree in Chemical Engineering, Mechanical Engineering or other engineering discipline.
- 4+ years of plant engineering experience.
Preferred Qualifications:
- 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.
RSREMD
Pay Range for this position: $76,200-$114,200
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
