Validation Engineer 1 at Millipore Corporation in Peterborough, New Hampshire

Posted in Other 12 days ago.





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:





  • Perform Qualification and Validation of Manufacturing Equipment, QC equipment, raw materials, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (temperature mapping and process qualification).

  • 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.

  • Collaborates 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.

  • Consults with management, assesses customer requirements, and studies 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.

  • Traveling up to 20%



Physical Attributes:


  • Lift up to 25 pounds.




Who You Are:




Minimum Qualifications:



  • Bachelors Degree in Chemical Engineering, Mechanical Engineering, or other Engineering discipline.

  • 1+ years of engineering work experience.




Preferred Qualifications:



  • Experience with ISO, cGMPs and Good Engineering Practices.




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
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