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Required::::::Validation Engineer :::: Portsmouth NH::::No H1B at Portsmouth, Virginia, USA
Email: [email protected]
Hi,

Hope you are doing well.

Below is the very urgent requirement please reviews it and let me know your interest
in this requirement. Would appreciate if you can also share your updated
resume.

Title: Validation
Engineer

Location:
Portsmouth NH

Duration: 6+
Months

Technology environment the consultant will be working
in:

Kneat

DeltaV

MODA

Consultants day to day responsibilities:

Execution of IQ and OQ protocols on existing biologics manufacturing
equipment including bioreactors, incubators, CIP/SIP systems and autoclaves

Temperature mapping and thermal uniformity testing of upgraded and new
equipment using Kaye. Documentation of test results.

Assessing change controls for process equipment and automation systems to
ensure they meet requirements to maintain validated status.

Reviewing and approving SOPs, change controls, deviation reports and all
supporting documentation.

Execution of CSV protocols for associated commercial software systems
including LIMS, MES and Master Control

Root cause analysis of any discrepancy reports generated during validation
execution and proposing CAPAs

Required Skills:

Bachelors degree in life sciences or engineering

5+ years of validation experience in a cell and gene therapy GMP environment.

Prior validation experience supporting a tech transfer project.

Previous experience with temperature mapping using Kaye equipment (Validator
and ValProbe systems.

Previous experience executing IQ, OQ, PQ on cell and gene therapy equipment
in a GMP environment. Some examples include: Bioreactors, Mixing tanks,
Distribution Systems,

Autoclave, Incubators, Refrigerators, Freezers, HPLC, TFF, Ultra filtration,
Autoclaves and CIP/SIP.

Prior experience using Kneat validation software in a GMP environment.

Best Regards,

Harsh Chaudhary

Technical Recruiter 1Points LLC

[email protected] ||

www.1pointsys.com

115 Stone Village Drive Suite C Fort Mill,
SC 29708

An E-Verified company | An Equal Opportunity
Employer

linkedin.com/in/harsh-chaudhary-702641198

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Keywords: information technology New Hampshire South Carolina
Required::::::Validation Engineer :::: Portsmouth NH::::No H1B
[email protected]
[email protected]
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Mon Aug 05 21:31:00 UTC 2024

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Location: Portsmouth, New Hampshire