Manufacturing Validation Engineer - Katalyst Healthcares & Life Sciences
North Haven, CT 06473
About the Job
Responsibilities:
- Process and equipment qualification (IQ/OQ/PQ).
- Development of test methods for Design V&V, Process Validation, and Production.
- Validation of test methods.
- Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work.
- Authoring/releasing of new test methods and editing/redlining of old test methods. Strong organizational skills, detail oriented.
- Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
- This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
- Expertise in medical device manufacturing and with 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 the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
- Strong organizational skills, detail oriented.
- Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.).
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
Source : Katalyst Healthcares & Life Sciences