Validation Engineer

Posted 07 Feb 2024

St. Louis, Missouri - United States

Req Id 271611

 

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: 

MilliporeSigma in St. Louis, MO is seeking a Validation Engineer.  This Validation Engineer will be the primary Validation Engineer for Cleanroom and Clean Environment Qualifications. This position will also support equipment and analytical instrument qualifications.  This role supports the manufacturing of pharmaceuticals in a cGMP manufacturing facility.

  • Develop, review, and approve validation 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.
  • Develop, review, and approve validation testing and protocols for equipment/analytical systems.
  • Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), and Maintenance.
  • Develop, review, and approve equipment/analytical instrument related Engineering Studies.
  • Analyze results from Engineering Studies to make conclusions and recommendations.
  • Author and review detailed design documents for facilities/equipment/analytical instruments.
  • Determine the impact of proposed changes on the validated state of facilities/equipment/analytical instruments.

 

Who You Are:

Minimum Qualifications:  

  • Bachelor’s Degree in Engineering, Life Sciences, Chemistry, or Biology
  • 1+ years quality or quality support experience in a cGMP pharmaceutical setting including experience in Deviation/CAPA support, root cause and risk assessment experience, and periodic review experience
  • 1+ years of cleanroom or clean environment operation experience
  • 1+ years of validation engineering experience
  • 1+ years of experience working with pharmaceutical standards, rules and guidance (e.g. FDA, EU, ISO, ISPE, etc.)

 

Preferred Qualifications:

  • Additional validation experience that may include equipment, process controls, process, cleaning, or temperature unit validation
  • Ability to utilize GDP during document creation and review
  • Comfortable in a fast-paced environment with the ability to adjust to changing priorities. Flexible and accountable
  • Awareness of EU Annex 1 Guide (Issued Year 2023)


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


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


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