Validation Engineer 2 - R&D

Merck-posted 2 days ago

Full-time • Mid Level

Bedford, MA

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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: MilliporeSigma in Bedford, MA is hiring a Validation Engineer 2. As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate on filtration product development teams to understand the new product and its applications. Your contribution includes development and implementation of an efficient and thorough validation test strategy which ensures robust product performance specifications based on product design and intended applications.

Authoring the validation test protocol, managing lab test requests, test execution, data analysis and authoring the report
Participate in process and product development supporting DOE studies and data analyses and creation of the product design specifications and risk assessments
Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications
Hands-on design and development of new test methods, test equipment, and measurement systems which are utilized to characterize and validate new products, including troubleshooting, repairs, and identifying and implementing equipment upgrades/new technology and planning, documenting, and executing test method validations
Effectively interact with other groups, such as R&D development teams, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance.
This position may include occasional travel to our manufacturing facilities <10%

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 4+ years of experience in process development/validation -OR- Master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 3+ years of experience in process development/validation
3+ years of experience with FMEA/risk analysis, product failure and root cause analysis
3+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

Experienced with Product Development Process (PDP) and working on cross functional teams
Experience using statistical tools such as Capability, Gage R&R, DOE in Minitab
Capable in the development and execution of test method validations
Working knowledge of quality principles including ISO, Quality Management Systems, Good Documentation Practices
Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements (CB Scheme/ UL testing) for systems used in biopharmaceutical processes
Proficiency in equipment calibration, trouble shooting and repairs
Familiarity with change control methodology
Experience with MilliporeSigma filtration and chromatography products

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

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