Validation Engineer III

Posted 07 Dec 2023

Jaffrey, New Hampshire - United States

Req Id 270336

 

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:

MilliporeSigma in Jaffrey, NH is seeking a Validation Engineer III.  In this role you will perform Qualification and Validation of Manufacturing Equipment, QC equipment, raw materials, and Supply chain equipment including FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), Installation and Operational Qualifications, and Performance Qualifications (temperature mapping and process qualification).

Responsibilities:

  • Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply.
  • Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
  • Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
  • Collaborate with Manufacturing, Engineering, Process Support, Supply Chain, Quality and R&D to ensure a specific product meets current regulation and quality standards.
  • Prepare, maintain, and review Validation documentation such as FAT, IQ, OQ, PQ, and process qualification. Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment and GMP production. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
  • Consult and recommend requirements with management, assess customer requirements, and study product characteristics to select validation objectives and standards.
  • Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification. Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems.

 

Physical attributes:

  • Ability to lift 25 pounds

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s degree in Engineering, Technical or Science field and 7+ years of experience in validation, quality, or manufacturing OR
  • Master’s degree in Engineering, Technical or Science field and 5+ years of experience in validation, quality, or manufacturing

 

Preferred Qualifications:

  • Knowledge of ISO, cGMPs and Good Engineering Practices
  • Knowledge of CSV and 21CFRPart11
  • Ability to manage multiple projects and participate on cross-functional project teams 

 



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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