Manufacturing Validation Specialist

4 weeks ago


New Haven, Connecticut, United States Next Level Business Services, Inc. Full time
Job Title: Manufacturing Validation Engineer

Next Level Business Services, Inc. is seeking a highly skilled Manufacturing Validation Engineer to join our team.

Job Summary:

We are looking for a detail-oriented and organized individual with a strong background in manufacturing engineering and validation. The successful candidate will be responsible for ensuring the quality and reliability of our medical devices by developing and implementing effective validation strategies.

Key Responsibilities:
  • Develop and execute validation plans for manufacturing processes and equipment
  • Conduct process and equipment qualification (IQ/OQ/PQ) activities
  • Develop and validate test methods for Design V&V, Process Validation, and Production
  • Execute Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
  • Author and release new test methods and edit/redline existing ones
Requirements:
  • Bachelor of Science in Engineering or equivalent combination of education and experience
  • 5+ years of relevant experience in medical device manufacturing
  • Expertise in medical device manufacturing and strong working knowledge of cGMPs
  • Clean room environment experience
  • Manufacturing Engineering and automation experience
  • Experience with Test Method Validation and/or Measurement System Analysis is preferred
  • Knowledge of computer software for data analysis, specifically Microsoft Excel and statistical packages (Minitab preferred)
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485
  • Strong organizational skills and attention to detail
  • Ability to collaborate with cross-functional teams and work to deadlines
  • Experience with Microsoft Office, including Word, Excel, PowerPoint, and Project
What We Offer:

Next Level Business Services, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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