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Urgent requirements for :: Manufacturing Validation Engineer :: North Haven, CT(Onsite) :: Medical Device Domain at North Haven, Connecticut, USA
Email: [email protected]
http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=1264975&uid=

From:

Nirbhay singh,

Appian infotech Inc

[email protected]

Reply to: [email protected]

Hi,

We Have Urgent requirements for

Manufacturing Validation Engineer

If you are interested in this position please share an updated profile on nirbhay.s

@appianinfotech.com ,

or call on 276-910-0146 Ext 128.

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:

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.

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
Urgent requirements for :: Manufacturing Validation Engineer :: North Haven, CT(Onsite) :: Medical Device Domain
[email protected]
http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=1264975&uid=
[email protected]
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09:45 PM 29-Mar-24


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Location: North Haven, Connecticut