Requirement of Sr. Validation Engineer at Los Angeles, CA

Hi,

 

Please let me know if you have someone available for the below mentioned position of Sr. Validation Engineer at Los Angeles, CA

 

Position Title – Sr. Validation Engineer

Location – Los Angeles, CA

Duration – 12 Months

Pay Rate – $70/hour (All Inclusive on C2C)

 

Description

In this position the consultant will work on exciting projects that are aimed towards enabling a Class A manufacturing organization.  These projects are aimed at increasing our manufacturing capabilities to enable the company to meets its growing business needs. This position will be part of the IT (Product Operations IT group) organization and will report into the IT Senior Manager for Validation & Change Management.

Responsibilities:
The Senior Validation Engineer will be responsible for developing and executing validation deliverables for IT supported IT systems.  The SVE will be responsible for working with team members to develop the Risk Control Strategy, validation protocols, test scripts and summary reports.

 

The SVE position will also provide testing guidance and direction to the application delivery team members in support of the end-end testing methodology.   This position will ensure appropriate collaboration with various internal customer groups. This position is also responsible for authoring, executing & providing oversight and review of deliverables such as user requirements, executed commissioning and deliverables to ensure ongoing compliance with all regulatory requirements.  The position will require staying current with company's Standards and industry standards, FDA regulations.  This position will also require interaction with the corporate compliance groups and FDA during audits to support IT validation packages and software related processes.

Minimum Qualifications:
Minimum 7 years of hands on IT and Computer Systems Validation.

Minimum 5 years of Biotech Experience

Familiarity with Risk Based methodology and risk management tools : FMEA and PHA.
Experience in authoring and execution of validation packages for Laboratory Management Systems, Document Management Systems and Manufacturing Execution systems is required.
Demonstrated experience in process improvement.
Demonstrated proficiency in interpretations of cGMP regulations, both US and international

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Thanks

Shivendra
iBusiness Solution LLC
Phone: 412-894-1929
Email: shivendra@ibusinesssolution.com

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