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Senior Validation Engineer
2 months ago
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.