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Senior Validation Engineer

2 months ago


Marlborough, Massachusetts, United States ProKatchers LLC Full time

Job Title: Senior Validation Engineer

Location: Marlborough, MA

Duration: 10 Months

Job Description:

  • We are seeking a highly experienced Senior Validation Engineer to join our team at ProKatchers LLC. The ideal candidate will have a strong background in verification and validation of processes, with a focus on new part development and manufacturing of plastic disposable kit products for a regulated industry.
  • The successful candidate will have well-founded knowledge and practical experience of relevant regulations, including ISO13485 and FDA 21 CFR Part 820, specifically for the US and European market product submission.
  • Responsibilities will include defining and managing Verification and Validation plans, test execution, results risk mitigation, statistical data analysis, and reports.
  • The ideal candidate will have hands-on experience with expertise in test method validation, Verification & Validation, mechanical testing, packaging design, transportation conditions simulation, and stability study.
  • We are looking for a detail-oriented and organized individual who can work effectively in a team environment and communicate complex technical information to both technical and non-technical stakeholders.