Sr Process Validation Engineer

Company:  Spark Life Solutions, Inc.
Location: Billerica
Closing Date: 08/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Roles & Responsibilities:
  • Process Validation (IQ/OQ/PQ)
  • Process Layout, Modeling, and Documentation
  • Equipment and Tooling Development
  • Process Development and Characterization
  • Test Method Development and Validation
  • Developing / Updating MPIs
  • Supplier Development and Component Engineering
  • Manufacturing Engineering Support / Engineering Documentation
  • Update work instructions to match the practice on the floor to what's in the procedure.
  • Create part numbers for some of the machine spare parts and supply items.
  • Update the tooling / fixture drawings to reflect what is used in the production floor
Education & Experience:
  • Bachelor's Degree in Engineering (e.g., Mechanical Engineering, Industrial Engineering, or a related field). A Master's degree is a plus.
  • 5+ years of experience in manufacturing engineering, process development, or a related field within a regulated industry
  • Hands-on experience in developing and optimizing manufacturing equipment and tooling.
  • Experience in developing and validating test methods for manufacturing processes.
  • Proficiency in updating work instructions, creating part numbers, and revising tooling/fixture drawings to reflect current production practices.
  • Certifications: Lean Six Sigma Green Belt or equivalent certification preferred.
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Spark Life Solutions, Inc.
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