| Requirements for :: Manufacturing Validation Engineer :: North Haven, CT at North, Virginia, USA |
| Email: [email protected] |
| From: Nirbhay singh, Appian infotech Inc [email protected] Reply to: [email protected] Role: Manufacturing Validation Engineer Location: North Haven, CT (Onsite) Job Type: Long term project JOB Description: 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 The education/experience I am looking for is as follows: 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. Questions to be asked to candidate (TA Team) 1. If having experience of validating Automated equipment Assembly Equipment In Manufacturing 2. If aware of the Vision System 3. If I have Experience with Process and equipment qualification (IQ/OQ/PQ) 4. If have experience of Development of test methods for Design V&V, Process Validation, and Production 5. Validation of test methods 6. If I have experience of Gauge R&R Studies, Attribute Analysis Studies, sampling 7. If having knowledge of medical device manufacturing and with strong working knowledge of cGMPs 8. If having experience of Test Method Validation and/or Measurement System Analysis 9. Clean room environment experience -- Regards Nirbhay Singh Appian Infotech Inc Contact No- 276 910 0146 Ext. 128 Email- nirbhay.s @appianinfotech.com LinkedIn:- https://www.linkedin.com/in/n-k-singh-430076245/ Keywords: access management rlang Connecticut Requirements for :: Manufacturing Validation Engineer :: North Haven, CT [email protected] |
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| Mon Apr 15 19:49:00 UTC 2024 |