[IEEE-bhpjobs] Fwd: CONTRACT: EQUIPMENT AND PROCESS-PA, NC, IL, NJ, MA and Mexico Job 52698

[EstherLumsdon]

---------- Forwarded message ----------
From: Scott
Date: Fri, 4 Apr 2008 03:21:59 -0700 (PDT)
Subject: CONTRACT: EQUIPMENT AND PROCESS-PA, NC, IL, NJ, MA and
Mexico    Job   52698
To: Computer Validation Jobs Report <computer-validation-jobs-
report at googlegroups.com>

Job  52698


Validation Engineers - Locations include PA, NC, IL, NJ, MA and
Mexico

Reading, Pennsylvania


Description:
Senior/Lead Validation Engineers ? This position is responsible for
developing, review, approval and in some cases execution of validation
documentation including VP, IQ, OQ, PQ, URS, FRS and DS to maintain
processes and equipment in a validated state. This position will also
provide guidance and training to user departments on the development
and execution of validation protocols.

The position will require experience in the validation of PLC's,
computer systems, manufacturing processes, sterilization equipment,
packaging lines, utilities and laboratory systems and equipment. This
person should be experienced with the development of SOP's, change
control and resolving deviations and validations in a medical devices/
pharmaceutical environment including experience with cGMP, 21 CFR Part
11. Experience with ISO 13485:2003 and SOX is considered an asset.

Qualifications

Minimum skills required are:
* BS or MS in Engineering, computer sciences or physical/life
sciences
* 5+ years of equipment and process validation in a pharmaceutical/
medical devices environment
* Be hands-on and field experienced
* Excellent time management skills
* Knowledge of GxP requirements
* Self starter with strong process improvement and quality skills
* Excellent written and oral communication skills
* Ability to manage multiple personnel and projects simultaneously
* Excellent decision making skills
Must have minimum 4 years Validation experience including facilities,
equipment, process, product, packaging validation for Medical Devices.
Experience in validating automated equipment and processes. GAMP4
expertise desirable.
Ability to write validation protocols and sometimes execute these
protocols.

Preferred skills requirement:
* BS or MS in Engineering
* 8+ years of validation experience
* Supervisory experience
* Significant manufacturing equipment validation experience.