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Validation Engineer at Remote, Remote, USA
Email: [email protected]
From:

Piyush Varshney,

Vyze Inc.

[email protected]

Reply to: [email protected]

Sr. Validation Engineer

Location: Southern NH (Onsite)

Duration: 6+ Months

MOI: Skype

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.

Project description:

This is a new client tech transfer into an existing cell therapy asset (2K).

Existing and new equipment needs to be validated and this includes bioreactors, autoclaves, freezers, incubators and associated utilities.

Will be a 1-2 year project and there will be the opportunity to support secondary projects.

The first phase of this tech transfer is starting in August 2024 and the goal is to have the project team established by September.

The current size of the team is 5-7 and is a mix of FTE and consultant resources.

Will be working with a larger cross functional team that includes engineering, manufacturing and quality.

This resource will increase the teams bandwidth and will be primarily supporting temperature mapping and CSV activities initially.

Technology environment the consultant will be working in:

Kneat

DeltaV

MODA

--

Piyush Vashney

Senior Technical Recruiter, VYZE INC

+1 703 982 7189

|

+91 8533070615

|

vyzeinc.com

[email protected]

24718 Tribe Square #306, Dulles VA 20166

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Mon Aug 05 21:05:00 UTC 2024

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