Validation Engineer

Merck KGaA, Darmstadt, Germany; St. Louis (MO); On-site; USD 73,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

MilliporeSigma in the United States is seeking a Validation Engineer to lead qualification and re-qualification of facilities, equipment, computer systems, and processes within an API Contract Manufacturing environment.

You will collaborate with cross-functional teams across Manufacturing, Project Management, Quality Control, and Engineering to ensure compliant validation activities, develop protocols, and oversee requalification while maintaining GMP standards.

Qualifications

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Biology, Chemistry, or Life Science discipline.
• 2+ years of engineering experience within a cGMP environment.
• 1+ years of experience with ISPE, PDA, USP, ICH and US 21CFR Parts 11, 210 and 211.

Responsibilities

• Provide support to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation.
• Prepare, review, and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes.
• Provide guidance and oversee the maintenance of the validated state including requalification/revalidation of equipment and processes
• Develop, review, and approve validation testing and protocols for equipment, cleanrooms, and clean environments in conjunction with other validation team members
• Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), Operational Technology (OT), and Maintenance
• Develop, review, and approve equipment/analytical instrument related Engineering Studies
• Analyze results from Engineering Studies to make conclusions and recommendations. Analyze Design documents for facilities/equipment/analytical instruments
• Evaluated the impact of proposed changes on the validated state of facilities/equipment/analytical instruments
• Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.

Skills

Engineering

Office software

Education

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

Tools

Microsoft Office

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 perform validation activities including qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and process validation. Active participation with site projects and multi-disciplinary teams with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance to ensure successful implementation and coordination of validation activities. Direct interaction with customers to understand specific validation requirements, ensuring customer needs are met specifically as an API Contract Manufacturing organization.

Responsibilities include but are not limited to:

• Provide support to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation.
• Prepare, review, and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes.
• Provide guidance and oversee the maintenance of the validated state including requalification/revalidation of equipment and processes
• Develop, review, and approve validation testing and protocols for equipment, cleanrooms, and clean environments in conjunction with other validation team members
• Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), Operational Technology (OT), and Maintenance
• Develop, review, and approve equipment/analytical instrument related Engineering Studies
• Analyze results from Engineering Studies to make conclusions and recommendations. Analyze Design documents for facilities/equipment/analytical instruments
• Evaluated the impact of proposed changes on the validated state of facilities/equipment/analytical instruments
• Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.

Minimum Qualifications:

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Biology, Chemistry, or other Engineering or Life Science discipline.
• 2+ years of engineering experience within a cGMP environment.

• 1+ years of experience of experience in regulations including ISPE, PDA, USP, ICH and US 21CFR Parts 11, 210 and 211.

Preferred Qualifications:

• Experience in technical writing.
• Strong attention to detail.
• Strong time management skills.
• Strong critical thinking skills to effectively troubleshoot and commission equipment and processes.
• Excellent communication skills, both oral and written.
• Experience reading, understanding, and following cGMPs, SOPs, specifications, and all guidelines.
• Experience interacting with customers or participating in regulatory audits
• Experience with Microsoft Office Applications.

Pay Range for this position: $72,700 - $118,700

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 perquisites. For more information click here.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variation 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!