We are looking for a Manufacturing Validation Engineer. Please let me know, if interested.
Manufacturing validation engineer
North Haven, CT
Full Time/Contract
Job Duties
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
education/experience
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.