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URGENT REQ: Manufacturing Validation Engineer_North Haven, Connecticut (60 Middletown Ave, North Haven, CT 06473) at North Haven, Connecticut, USA
Email: [email protected]
From:

Abhishek Mukherjee,

Appian Infotech

[email protected]

Reply to:   [email protected]

Hi,

Abhishek Mukherjee here from Appian InfoTech. I am actively looking for a Manufacturing Validation Engineer at North Haven, Connecticut (
60 Middletown Ave, North Haven, CT 06473). Please let me know if youre looking for a change. The Job Description is attached below for your reference.

I can be reached at [email protected] or call me on 276-910-0140

Manufacturing Validation Engineer

No of position: 2

Location: North Haven Connecticut (
60 Middletown Ave, North Haven, CT 06473)

PTO/Holiday (If Offered): Yes: 1 Week

Duration: 12+ months

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

The education/experience I am looking for is as follows:

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.

Keywords: access management rlang Connecticut
[email protected]
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Wed Mar 20 21:32:00 UTC 2024

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Location: North Haven, Connecticut