Validation Engineer I - A Shift Job at MilliporeSigma

MilliporeSigma Jaffrey, NH 03452

Work Your Magic with us!
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 unimageable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the 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 resolve the extent of failure on the validation test.
  • Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
  • Implement 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.
  • A Shift: Monday - Friday 8AM - 5PM

Physical Attributes
Able to lift 25 pounds
Who You Are:
Minimum Qualifications:

  • B.S. in Engineering

Preferred Qualifications:

  • Knowledge of ISO, cGMPs and Good Engineering Practices
  • Ability to manage numerous projects and participating on multi-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
Job Requisition ID: 258467
Location: Jaffrey
Career Level: B - Recent University Graduate(< 1> Working time model: full-time
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, 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.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information .
Nearest Major Market: Bellows Falls
Nearest Secondary Market: Keene
Job Segment: QC, Developer, Quality, Technology

Job Type: Full-time




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