Product Validation Engineer 3 - R&D

The businesses of Merck KGaA, Darmstadt, Germany • Bedford, MA

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About The Position

MilliporeSigma in Bedford, MA is seeking a Product Validation Engineer 3. 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. You will implement an efficient and thorough validation test matrix, including development of new test equipment and test methods.

Requirements

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 7+ years of experience in process or product development/validation -OR- Master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 5+ years of experience in process or product development/validation
• 5+ years of experience with FMEA/risk analysis, product failure and root cause analysis
• 5+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

Nice To Haves

• Experience in Medical Device or Life Science industries
• Experience with filtration, and chromatography products
• Experience in the development and execution of test method validations
• Experience using statistical tools such as Minitab for Capability analysis, Gage R&R’s, & DOE’s
• Experience with Product development process and working on cross functional teams
• Experience leading/supervising a small team
• Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry
• Proficiency in equipment calibration, trouble shooting and repairs
• ASQ – CQE Certification

Responsibilities

• Authoring the validation test protocol, test execution oversight, data analysis, and authoring the validation report
• Participate in process and product development supporting DOE studies and data analyses and creation of the product design specifications and risk assessments
• Participate in development of the product design specifications, risk assessments, and coordinate testing for shelf-life studies
• Planning, documenting, and executing test method validations
• Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer application inquiries
• Interact effectively 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%

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees