Validation Engineers III
Millipore Corporation

Job Info

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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.

Position: Validation Engineers III

Employer: EMD Millipore Corporation

400 Summit Drive

Burlington, Massachusetts 01803

Job Site: 11 Prescott Road

Jaffrey, New Hampshire 03452

Responsibilities:

The Validation Engineer III will apply comprehensive working knowledge of GMPs (Good Manufacturing Practices), GLPs (Good Laboratory Practices), GAMP (Good Automated Manufacturing Practices) and Part 11 compliance as they relate to qualification of systems in support of validation of processes. Specific duties include:

Creating and implementing standardized manufacturing processes to maintain operational efficiency and reliability;

Troubleshooting and resolving issues encountered during field tests;

Authoring documents pertaining to standard operating procedures, impact assessments, and final reports regarding validating processes;

Performing deviation investigations, troubleshooting issues encountered during field execution activities, and generating deviation reports as required;

Promoting and integrating cGMP (Current Good Manufacturing Practices; enforced by the U.S. Food and Drug Administration) regulatory compliance and quality by design (QbD) approaches into assigned projects;

Generating and reviewing equipment specifications, owner project requirements, specifications, checklists and test data; and

Managing project documentation such as protocols, reports, calibration certificates, and process trends.

Requirements & Qualifications:

Employer requires a bachelor's degree in mechanical engineering, industrial engineering, or a closely related field and five (5) years of progressively more responsible work experience as a quality engineer, validation engineer, industrial engineer, or similar occupation responsible for adhering to cGMP or ISO requirements. In addition, employer requires:

Demonstrated ability performing process optimization for production or assembly lines and ensuring proper documentation at each stage of the process validation lifecycle gained through four (4) years of work experience;

Demonstrated ability performing data collection and sampling and utilizing Minitab and MS Excel to analyze data and implement data driven solutions gained through four (4) years of work experience;

Demonstrated ability writing and executing IQ, OQ, and PQ protocols and user requirement specifications gained though four (4) years of work experience;

Demonstrated ability writing protocols for PLCs and performing testing, troubleshooting, and qualification of automated and computerized systems gained through four (4) years of work experience;

Demonstrated ability performing project management and acting as a team lead within a cross-functional environment gained through four (4) years of work experience; and

Demonstrated ability performing temperature mapping and validating laboratory, manufacturing, and facilities equipment gained through four (4) years of work experience.

In the alternative, employer would accept a master's degree in mechanical engineering, industrial engineering, or a closely related field and three (3) years of work experience as a quality engineer, validation engineer, industrial engineer, or similar occupation responsible for adhering to cGMP or ISO requirements. In addition, employer requires:

Demonstrated ability performing process optimization for production or assembly lines and ensuring proper documentation at each stage of the process validation lifecycle gained through two (2) years of work experience;

Demonstrated ability performing data collection and sampling and utilizing Minitab and MS Excel to analyze data and implement data driven solutions gained through two (2) years of work experience;

Demonstrated ability writing and executing IQ, OQ, and PQ protocols and user requirement specifications gained though two (2) years of work experience;

Demonstrated ability writing protocols for PLCs and performing testing, troubleshooting, and qualification of automated and computerized systems gained through two (2) years of work experience;

Demonstrated ability performing project management and acting as a team lead within a cross-functional environment gained through two (2) years of work experience; and

Demonstrated ability performing temperature mapping and validating laboratory, manufacturing, and facilities equipment gained through two (2) years of work experience.

All years of experience may be gained concurrently.

This position is eligible for EMD Millipore Corporation's Employee Referral Program.

Applicants can send resumes to EMD Millipore Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req#283219 ) or apply online at https://careers.emdgroup.com

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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