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Process Validation Engineer || Bay Area, CA (Onsite) at Bay, Arkansas, USA
Email: [email protected]
Hi,  

Hope you are doing well!! Please find the job description detailing the preferred specifications that our client is seeking for this position.

Title:  Process Validation Engineer

Location: Bay Area, CA (Onsite)

Start Date: Immediate

Duration: 12 months plus

Qualifications:

A minimum of a Bachelor of Science Degree in a technical
field (for example, Electrical Engineering, Mathematics, Statistics, Mechanical
Engineering, Industrial Engineering, Chemical Engineering, etc.) is required.

A minimum of 2-4 years of experience in a technical field
is preferred.

Experience with GR&R, FMEA (Failure Modes Effects
Analysis), DOE and process characterization is preferred.

Experience with Process Validation (IQ/OQ/PQ), able
to generate protocols and test reports.

Experience with statistical analysis software tool such as
MiniTab is preferred.

Knowledge of LEAN/ Six Sigma and Process Six
Sigma is preferred.

Understanding of Statistical Analysis used to identify
issues in post-market surveillance, complaints, and servicing is preferred.

Understanding of Risk Management (Medical Device) is
preferred.

Strong integration skills to identify Manufacturing and
Supplier related issues of Medical Device Capital Equipment is preferred.

Demonstrated ability to work effectively with
cross-functional teams for qualifications, verifications, validations,
complaint investigation, root cause analysis, identification and implementation
of CAPAs is preferred.

Ability to multi-task with an established track record of
meeting milestone schedules is preferred.

Prior experience or training in Validation Engineering
is preferred.

Experience working in an ISO13485, GMP, or FDA
regulated environment is desirable.

Excellent communication skills, both verbal and written,
and the ability to effectively interface within a cross-functional teams.

Thanks and Regards

Technical Recruiter

Sumit Shahi

Cloud
Space LLC

Email: [email protected]

Website: www.cloudspacetek.com

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Keywords: rlang information technology California
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Wed Feb 07 00:40:00 UTC 2024

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