GMP Engineering and Maintenance Compliance Associate
Millipore Corporation

Job Info

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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.

Your Role:

Reporting to the Head of Engineering, the Engineering and Maintenance Compliance Specialist's primary role is to provide support to the cGMP operations. This position will be responsible for assisting Engineering, Manufacturing, and Validation with quality support as it relates to SAP CMMS admin., change control, equipment non-conformances, equipment deviations, routine maintenance plan updates, and Building Management System alarm response and support. Additional responsibilities may include on the floor oversight during maintenance shutdowns, incident investigations and resolution, monitoring of the building management system. Job Responsibilities include:

• Coordinate documentation and tasks associated with equipment and facilities.
• Change management.
• Addition of new equipment to SAP
• Addition of Preventative maintenance and Calibration plans.
• Technical document writing of reports, quality records, and maintenance plans.
• Alarm response tracking.
• Work with Engineering, Technical Operations, Maintenance, Manufacturing, Validation, and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved and implemented as appropriate
• Assist with equipment and facility investigations, troubleshooting, and root cause analysis
• Assist with the management of preventative maintenance tasks, change control, and equipment/facility shut-down activities.
• Perform updates to CMMS in compliance with cGMP.
• Generate, review and close work orders as needed in CMMS.
• Assist with equipment and facility risk assessments and mitigation
• Ensure planned and unplanned work is prioritized and managed closely to minimize disruptions to Operations' schedule.
• Maintenance of quality systems and cGMP compliance for Engineering, Maintenance, and Validation.
• Ability to understand regulatory requirements such as ICH Q7
• Support equipment commissioning, qualification, and validation activities related to GMP manufacturing.
• Create new assets and spare parts in CMMS
• Write, review and/or assist in the development of Facility and Equipment Operating Procedures
• Assist with internal, customer, and regulatory audits
• Write Engineering and Maintenance CAPA, deviation, and change control
• Write Quarterly alarm trending reports.
• Drive continuous improvement to Engineering and maintenance practices to support customer and regulatory expectations.

Who You Are

Minimum Qualifications:

• Associate Degree in a Chemistry, Controls Engineering, or other STEM discipline.

OR

• Vocational degree or certification in industrial maintenance, electronics, or other trade.
• 1+ years of experience in a GMP manufacturing or industrial role.

OR

• High School Diploma or GED
• 1+ years of experience in equipment systems administration

Preferred Qualifications:

• Associate Degree in Controls or Mechanical Engineering.
• 2+ years of experience in equipment systems administration
• Experience with TrackWise, Mango, and SAP or other QMS and CMMS systems, specifically for Quality Management and Engineering.
• Ability to work within a cross-functional team.
• Effective oral and written communication skills.
• Demonstrated use of Good Documentation Practices.

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!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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