Senior Validation Manager
About The Position
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. 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.
Requirements
- Bachelor's degree in chemical engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 10+ years of experience in process development/validation OR- Master's degree in chemical engineering, Biomedical Engineering, Mechanical Engineering, or other 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
