Validation Manager
Company: emd serono
Location: Bedford
Posted on: January 2, 2026
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Job Description:
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. Thats
why we are always looking for curious minds that see themselves
imagining the unimaginable with us. This role does not offer
sponsorship for work authorization. External applicants must be
eligible to work in the US. Your Role: As a Validation Manager in
the R&D Validation & Applications Center (VAC), you lead
engineers to validate new Aseptic, Virus clearance & clarification
Filtration products. You effectively allocate and manage resources
to ensure validation activities and deliverables are completed on
time and meet high-quality standards. You guide your team in the
development and validation of new test equipment and methods,
providing technical consultation on validation topics to product
development teams. You understand when and how to leverage the
flexibility within our product development processes appropriately.
In addition to managing employee performance, you identify training
and development opportunities to foster team growth. You offer
leadership and strategic guidance to the VAC team, driving
data-driven problem-solving and continuous improvement initiatives
that impact both the VAC and product development teams. You
effectively collaborate with R&D, Quality, Project Management,
Product Management, Operations / Manufacturing, EHS and Facilities.
Who You Are Minimum Qualifications: • Bachelor’s degree in an
Engineering field with 8-10 years of experience in process
development/validation -OR- Master’s degree in an Engineering field
with 7 years of experience in process development/validation • 7
years of experience with product/process/system validations
(IQ/OQ/PQ) • 7 years of experience with FMEA/risk analysis, product
failure and root cause analysis • 5 years of experience using
statistical tools such as Gage R&R, DOE, capability analysis
and data analysis in Minitab or equivalent Preferred
Qualifications: • Leadership training and experience managing
engineers and/or lab personnel including employee performance
evaluations • Cross functional work experience in product
development, process development or validation • Comprehensive
understanding of quality principles including ISO, quality
management systems, Good Documentation Practices • Knowledge of FDA
Regulations, USP requirements, and other regulatory and compendial
requirements applicable to biomanufacturing process and equipment •
Understanding of new product development processes • Proficient in
equipment calibration, troubleshooting and repair • Experience with
capital equipment projects and equipment design, development, and
upgrades • Experience developing and executing test method
validations • Working knowledge of safety and ergonomics principles
• Experience with MilliporeSigma filtration, chromatography and
Mobius products • Experience with plastics processing • Experience
with change control methodology • Formal management training • ASQ
– CQE Certification
Keywords: emd serono, Newton , Validation Manager, Engineering , Bedford, Massachusetts
