Validation Engineer

The businesses of Merck KGaA, Darmstadt, Germany; St. Louis (MO); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Validation Engineer to oversee Cleanroom and Clean Environment Qualifications in a cGMP facility. The role involves developing protocols, supporting cross-functional teams, and ensuring compliance with pharmaceutical standards. If you are detail-oriented with experience in validation engineering, apply now!

Benefits

Opportunities for growth and development

Inclusive work culture

Qualifications

• Minimum 3 years experience in a cGMP environment.
• Bachelor’s in a relevant field preferred.
• Experience with pharmaceutical standards (FDA, ISO).

Responsibilities

• Develop and approve validation testing protocols for cleanrooms.
• Support cross-functional teams during protocol execution.
• Review design documents for facilities and equipment.

Skills

Collaboration

Attention to Detail

Problem Solving

Education

Associate’s Degree

Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Biology, or other Life Science discipline

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.

Your Role:

In this role you will be the Validation Engineer for Cleanroom and Clean Environment Qualifications. This position may also support equipment and analytical instrument qualifications with further opportunities. This role supports the manufacturing of pharmaceuticals in a cGMP manufacturing facility.

• Develop, review, and approvevalidation testing and protocols for cleanrooms and environments in conjunction with other validation team members.
• Provide support to Engineering, Maintenance, Manufacturing and QA teams during Protocol execution.
• Work cross-functionally with Manufacturing, Project Management,Quality Control, Quality Assurance, Packaging, Materials Management, Engineering,Information Technology (IT),and Maintenance.
• Review detailed design documents for facilities, equipment and analytical instruments.
• Determine the impact of proposed changes on the validated state of facilities, equipment and analytical instruments.
• Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.

Who You Are:

Minimum Qualifications:

• Associate’s Degree in any discipline and 3+ years of experience within a cGMP environment

OR

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Biology, or other Engineering or other Life Science discipline.

Preferred Qualifications:

• 1+ years quality or quality support experience in a cGMP pharmaceutical setting.
• 1+ years of cleanroom or clean environment operation experience.
• 1+ years of validation engineering experience.
• Experience of pharmaceutical standards, rules and guidance (e.g. FDA, EU, ISO, ISPE, etc.).

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!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!