GMP Engineering Specialist

MilliporeSigma; St. Louis (MO); On-site; USD 64,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Job summary

MilliporeSigma in St. Louis, MO, seeks a role to support CMMS administration, change control, deviations, CAPAs, and quality documentation. The facility at 3300 South Second Street serves as the base for daily operations.

You will coordinate validation, maintenance, and engineering documentation, track alarms, assist audits, and ensure cGMP compliance with strong communication and document control skills.

Qualifications

• Associate Degree in Chemistry, Biology, Controls Engineering, Mechanical Engineering or other Life Science or Engineering Discipline.
• Vocational degree or certification in industrial maintenance or related field with 1+ years GMP experience.
• High School Diploma/GED with 3+ years GMP manufacturing experience.

Responsibilities

• Coordinate validation, maintenance, and engineering documentation and tasks.
• Author technical reports, quality records, maintenance plans, and operating procedures.
• Manage Change Controls, Deviations, and CAPAs in the QMS across cross-functional teams.

Skills

Cross-functional teamwork

Oral & written communication

Documentation management

Attention to detail

Education

Associates degree in Chemistry/Biology/Engineering

Vocational certification in industrial maintenance

High School Diploma with GMP experience

Tools

TrackWise

Mango

SAP or other QMS/CMMS systems

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.

Responsibilities Include But Are Not Limited To

• 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.

OR

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

OR

• 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

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 prerequisites. For more information click here.

RSREMD

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!