GMP Equipment Engineer
Millipore Corporation

Job Info

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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 environmentKnowledge/understanding of DCS and BMS systems automation (ie. Delta V, PLC, and Siemens)Knowledge/understanding of data historian, data integrity, and IoT networkingKnowledge/understanding of FDA, cGMP regulationsAbility to read and create electrical schematics, P&IDs, instrument loop diagrams, design specification, and validation protocolsExcellent communication skills, interpersonal skills, technical writing skills, creative problem-solving skills, and a team-oriented attitude RSREMD

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