Validation Engineer III

The businesses of Merck KGaA, Darmstadt, Germany; St. Louis (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

Join a leading company as a Validation Specialist. In this role, you will engage in validation processes and collaborate with various teams to ensure compliance in a cGMP environment. A minimum of 10 years’ experience is essential, along with a degree in Engineering or Life Sciences. If you're ready to apply your skills and grow in a diverse, inclusive atmosphere, we would love to hear from you!

Benefits

Diversity and Inclusion Programs

Career Development Opportunities

Qualifications

• Bachelor’s degree in Engineering or Life Sciences discipline or equivalent experience.
• Minimum 10 years’ experience in a similar role within a cGMP environment.
• Competence in regulations including ISPE, PDA, USP, ICH, US 21CFR.

Responsibilities

• Validate and re-qualify facilities, utilities, and processes.
• Prepare, review, and approve documentation for validation activities.
• Provide guidance on maintaining validated states of equipment.

Skills

Project Management

Risk Management

Technical Writing

Critical Thinking

Microsoft Office

Communication

Attention to Detail

Education

Bachelor’s degree in Engineering or Life Sciences

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

Validation activities include 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:

• 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.

Who You Are

Minimum Qualifications

• Bachelor’s degree in an Engineering or Life Sciences discipline and/or equivalent years of practical experience
• Minimum 10 years’ experience of a similar role within a cGMP environment is essential, complimented with basic project management knowledge.
• Must be able to apply a risk-based approach to operation and interpretation of resulting data.
• Competent in regulations including ISPE, PDA, USP, ICH and US 21CFR Parts 11, 210 and 211.

Preferred Qualifications:

• Experience as a team lead; ability to coach, motivating, and occasionally managing a team of peers.
• Experience in technical writing.
• Mechanical aptitude required. Possess critical thinking skills to troubleshoot and commission equipment/processes.
• Proficient in Microsoft Office Applications.
• Excellent communication skills, both oral and written. Ability to work as part of a team and provide leadership.
• Must be able to read, understand and follow cGMPs, SOPs, Specs, and all guidelines as they relate to the process.
• Time management skills and the ability to manage oneself. Projects must be completed in a timely manner and per the testing timelines.
• Superior attention to detail.
• Experience in interaction with regulatory bodies.
• Knowledge of API products and CMO is desirable but not essential.
• Ability to liaise with customer and intercept their requirements.
• Demonstrated ability to coach develop staff and work effectively will all levels of organization.

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