[Biodevelopers] (job) SW Validation Engineer - New Jersey

Khristine khristine at earthlink.net
Tue Sep 3 14:25:22 EDT 2002

SW Validation Engineer - New Jersey

I am actively recruiting a Software Validation Engineer for a client, one of
the leading generic pharmaceutical manufacturers
and marketers in the United States, located in New Jersey. Here is more

Key Responsibilities:
1) Responsible for maintenance and dissemination of policies and procedures
surrounding computer validation
2) Responsible for evaluating system projects and recommending an
appropriate validation approach to ensure Regulatory Compliance.
3) Responsible for the life cycle management/change control of validated
computer systems
4) Provide direction and template documents so as to centralize and
standardize computer validation procedures.
5) Create and provide computer validation training programs to ensure
Regulatory Compliance.
6) Work to investigate and develop synergies for computer validation.
7) Keep abreast of new and upcoming industry trends towards Computer
Validation and disseminate the information as required.
B.S. in Computer Science, Technical Field (or related field) required
Minimum 5 years Computer-based experience, with 3 years of computer systems
validation or related experience required.

Specialized Skills and Knowledge:
1) Thorough knowledge and understanding of the Software Development Life
Cycle approach to computer systems development.
2) Thorough Knowledge of Computer Hardware, Client/Server architecture and
implementation strategies, LAN/WAN infrastructure, and Operating System (OS)
environments(e.g.  Microsoft, UNIX).
3) Well-versed in the principles of general validation activities, including
Requirements, Design, Installation Qualification, Operational Qualification
and Performance Qualification.
4) Advanced knowledge of cGMP, especially in the areas of computer or
related systems use, and documentation procedures.
5) Interactive experience with Regulatory Agencies
6) PC literate at an advanced level, along with an understanding of software
applications, DCS, SCADA, and PLC.
7) Basic knowledge of pharmaceutical manufacturing and statistical
8) Ability to interact well with a variety of personalities, craft skills,
and educational levels. Ability to work independently with no direct

What do you think? If you are interested in pursuing this opportunity,
please forward to workwonders at earthlink.net:

-your resume in word or text format
-your salary requirement
-your citizenship status.

If you aren't interested or feel you are not qualified, do you know anyone
who would be interested? We do offer generous referral fees.

Thanks for your time and have a great day!

Khristine Anderson
khristine at earthlink.net

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