Validation Manager

Merck•Bedford, MA

15d•Onsite

About The Position

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

Requirements

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

Nice To Haves

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

Responsibilities

lead engineers to validate new Aseptic, Virus clearance & clarification Filtration products
allocate and manage resources to ensure validation activities and deliverables are completed on time and meet high-quality standards
guide your team in the development and validation of new test equipment and methods
providing technical consultation on validation topics to product development teams
managing employee performance
identify training and development opportunities to foster team growth
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
effectively collaborate with R&D, Quality, Project Management, Product Management, Operations / Manufacturing, EHS and Facilities