GMP Engineering Specialist

Millipore Corporation; St. Louis (MO); On-site; USD 43,000 - 66,000; Full time

Benefits offered by this job

health insurance

paid time off (PTO)

retirement contributions

other prerequisites

Job summary

MilliporeSigma is seeking a qualified engineer/technician to support CMMS administration, validation, and maintenance at the 3300 South Second Street facility in Missouri.

You will coordinate documentation, manage change controls and CAPAs, and assist with audits while ensuring cGMP compliance and effective alarm monitoring.

Qualifications

• Associate/Vocational degree relevant to life sciences or engineering.
• GMP manufacturing experience preferred or equivalent.
• Demonstrated good documentation practices and attention to detail.
• Experience with TrackWise, Mango, SAP or CMMS in cGMP.

Responsibilities

• Coordinate validation, maintenance, and engineering documentation tasks.
• Author technical reports, quality records, and operating procedures.
• Manage changes, deviations, and CAPAs across cross-functional teams.
• Lead equipment investigations, root cause analysis, and risk assessments.
• Maintain CMMS records, calibration plans, and work orders.
• Support commissioning, qualification, validation, and preventive maintenance.
• Track alarm responses and prepare quarterly reports.
• Assist audits and provide on-the-floor oversight during shutdowns.

Skills

GMP manufacturing experience

Good Documentation Practices

Attention to detail

Cross-functional collaboration

Education

Associate Degree in Chemistry/ biology/ controls eng/ mechanical eng

Vocational degree or certification in industrial maintenance

High School Diploma or GED + 3+ years GMP experience

Bachelor's Degree in Engineering or Science

Tools

TrackWise

Mango

SAP or other QMS/CMMS

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

In this role you will be responsible for assisting Engineering, Maintenance, and Validation with quality support as it relates to CMMS administration, change control, equipment non-conformances, equipment deviations, routine maintenance plan updates, technical document creation, and alarm response tracking and reporting. This position is located at the 3300 South Second Street facility.

• Coordinate validation, maintenance, and engineering documentation and operational tasks.
• Author technical reports, quality records, maintenance plans, and Facility/Equipment Operating Procedures.
• Manage Change Controls, Deviations, and CAPAs in the QMS across cross-functional teams (Engineering, QA, Manufacturing, Validation).
• Manage equipment/facility investigations, troubleshooting, root cause analysis, and risk assessments.
• Maintain CMMS by updating records, creating new equipment/calibration plans, and generating, reviewing, and closing work orders in compliance with cGMP.
• Support equipment commissioning, qualification, validation, and preventative maintenance shut-down activities.
• Track alarm responses and prepare quarterly operational reports.
• Assist with internal, customer, and regulatory audits, providing on-the-floor oversight and building management system monitoring during shutdowns.

Minimum Qualifications

• Associate Degree in Chemistry, Biology, Controls Engineering, Mechanical Engineering or other Life Science or Engineering Discipline.
• Vocational degree or certification in industrial maintenance, electronics, or other trade and 1+ years of experience in a GMP manufacturing industrial role.
• High School Diploma or GED and 3+ years of experience in a GMP manufacturing industrial role.

Preferred Qualifications

• Bachelor's Degree in Engineering or Science discipline.
• 2+ years of experience in cGMP Quality, Engineering, or Manufacturing.
• Experience with TrackWise, Mango, SAP or other QMS and CMMS systems in cGMP environment.
• Ability to work within a cross-functional team.
• Effective oral and written communication skills.
• Demonstrated use of Good Documentation Practices.
• Strong computer and document management skills with sharp attention to detail.

Pay Range for this position

$31 - $48 / hour

Benefits offered by the Company

• health insurance
• paid time off (PTO)
• retirement contributions
• other prerequisites

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!