Manufacturing Process Validation Specialist

2 days ago


Billerica, Massachusetts, United States Spark Life Solutions, Inc. Full time
Process Validation Engineer

At Spark Life Solutions, Inc., we are seeking a highly skilled Process Validation Engineer to join our team. As a key member of our manufacturing engineering team, you will be responsible for ensuring the quality and reliability of our manufacturing processes.

Key Responsibilities:
  • Develop and implement process validation strategies to ensure compliance with regulatory requirements.
  • Design and develop manufacturing equipment and tooling to optimize process efficiency and quality.
  • Collaborate with cross-functional teams to develop and validate test methods for manufacturing processes.
  • Update work instructions and create part numbers to reflect current production practices.
  • Develop and maintain process documentation, including process layouts, models, and MPIs.
Requirements:
  • 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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