Validation Manager (Bedford, Massachusetts, US, 01730) en None

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.  

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 

This position may include occasional travel to our manufacturing facilities <10% 

This role must be based in the Bedford, MA site

 Pay Range for this position: $114,700 - $219,500. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!