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)


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.

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 *audit*s 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 *


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

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