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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:
At MilliporeSigma in St. Louis, MO, the GMP Maintenance and Engineering department is responsible for supporting the GMP Manufacturing facilities and equipment at the Cherokee site. Reporting to the Head of Facility Engineering, the incumbent will be responsible for the engineering and performance of manufacturing equipment, Electronic Controls, and Instrumentation for the GMP facilities at the Cherokee site.
The GMP Equipment Engineer is recognized as a strong technical contributor within the Engineering Team supporting manufacturing equipment, maintenance, project engineering, controls and instrumentation, and validation/QA as a SME.
Responsibilities:
Overall asset management of Biopharmaceutical manufacturing equipment including maintenance, calibration, data integrity, system administration, and maintaining the qualified state of validated manufacturing equipment.
Execute scheduled preventative maintenance, data integrity audit trail review, and period reviews on validated manufacturing equipment.
Troubleshoot automated control systems, instruments, and process equipment. Work with Technicians as the Escalation resource for emergency breakdowns and alarms throughout the GMP facilities.
Oversee work done by contract service providers to ensure cGMP compliance.
Write, review and/or assist in the development of Manufacturing, Facility and Equipment Operating Procedures.
Create User Requirement Specifications, Functional Specifications, and Design Specifications Support development of documentation for equipment commissioning, qualification and validation activities related to GMP manufacturing equipment.
Project management, oversight, scheduling, and coordination of capital projects.
Who You Are:
Minimum Qualifications:
Bachelor’s Degree in Engineering, Life Sciences, Chemistry, Biology, or other Electrical, Engineering or Science degree and 2+ years of engineering experience
-OR-
Associate’s Degree in Engineering, Life Sciences, Chemistry, Biology, or other Electrical, Engineering or Science degree and 5+ years of engineering experience
Preferred Qualifications:
In-depth knowledge of process/analytical instrumentation, process controls, and Biopharmaceutical process equipment
Extensive “hands on” experience in the manufacturing environment
Knowledge/understanding of DCS and BMS systems automation (ie. Delta V, PLC, and Siemens)
Knowledge/understanding of data historian, data integrity, and IoT networking
Knowledge/understanding of FDA, cGMP regulations
Ability to read and create electrical schematics, P&IDs, instrument loop diagrams, design specification, and validation protocols
Excellent communication skills, interpersonal skills, technical writing skills, creative problem-solving skills, and a team-oriented attitude
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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!