Validation Engineer 3 - R&D

Merck KGaA-posted 2 months ago
Full-time • Mid Level
Bedford, MA
5,001-10,000 employees
Chemical Manufacturing
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MilliporeSigma in Bedford, MA is seeking a 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.

  • Authoring the validation test protocol, test execution oversight, data analysis, and authoring the validation report
  • 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 Facilities, Engineering Services, Finance, EHS & Quality
  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 7+ years of experience in process development/validation
  • OR-
  • Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 5+ years of experience in process development/validation
  • 5+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)
  • 5+ years of experience with FMEA/risk analysis, product failure and root cause analysis
  • 3+ years of 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
  • Working knowledge of quality principles including ISO, Quality Management Systems
  • 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
  • Experience with MilliporeSigma filtration, and chromatography products
  • Experience with change control methodology
  • Working knowledge of EHS guidelines and ergonomics principles
  • Experience with equipment development, URS, GAMP, software validation, PLC and controls, and plastics processing
  • ASQ - CQE Certification
  • health insurance
  • paid time off (PTO)
  • retirement contributions
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