Job Id
291354
Jaffrey, New Hampshire, United States
Job Type
Full-time
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.
Job Title: Validation Engineers II
Employer: EMD Millipore Corporation, 400 Summit Drive, Burlington, MA 01803
Job Location: EMD Millipore Corporation, 11 Prescott Road, Jaffrey, NH 03452

Job Responsibilities:

• Design and Lead intermediate to complex level equipment, and process validations activities;
• Lead investigations on validation protocol discrepancies to identify the root causes;
• Lead change requests in Change Management system, ensuring implementation solutions, support operational needs and meet quality standards;
• Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification;
• Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials;
• Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated state;
• Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer’s specification and functional requirements;
• Prepare, maintain, and review Validation documentation for DQ, 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
• Consult with management and assess customer requirements to select validation objectives and standards.

10% domestic travel and 5% international travel is required.
Job Requirements:
Employer requires a bachelor’s degree in engineering, computer science, or a closely related STEM field, and two (2) years of work experience as a Validation Engineer, or related occupation, providing computer and equipment validation lifecycle experience.

In addition, employer requires:

• Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in a startup Biotechnology industry gained through two (2) years of work experience;
• Demonstrated knowledge of FDA 21 CFR Part 11 regulations gained through one (1) year of work experience;
• Demonstrated knowledge of temperature mapping of controlled temperature units gained through one (1) year of work experience; and
• Demonstrated ability performing Root Cause Analysis with robust Corrective and Preventive Actions in Life Science industry gained through one (1) year of work experience.

All years of experience may be gained concurrently.
This position is eligible for the EMD Millipore Corporation Employee Referral Program.
Applicants can mail resumes to EMD Millipore Corporation., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 291354 or apply online at https://www.emdgroup.com/en/careers/job-search.html)
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!
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

• Design and Lead intermediate to complex level equipment, and process validations activities;
• Lead investigations on validation protocol discrepancies to identify the root causes;
• Lead change requests in Change Management system, ensuring implementation solutions, support operational needs and meet quality standards;
• Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification;
• Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials;
• Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated state;
• Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer’s specification and functional requirements;
• Prepare, maintain, and review Validation documentation for DQ, 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
• Consult with management and assess customer requirements to select validation objectives and standards