Sunday, February 7, 2010

[itroundtable] LEAD: Val Eng - NJ - 9 mos contract

 

Direct Client - Validation Engineer 
Pharmaceutical Industry Background

 

Princeton - NJ

Contract -  9 months

Need In-person interview

 

Job Description:

 

Validation Engineer Reports to: Manager, Validation Services Overview: This person will perform validation of computer systems in an FDA-regulated environment.  Responsible for preparation of change control and validation documents, preparation of summary reports, and preparation of test scripts.

 

Responsibilities:

 

  • Preparation of change control documents, including validation approach.
  • Prepare all validation documentation including Validation Plans, OQ Protocol and other required documents 
  • Development of test strategies for Off-The-Shelf and custom applications
  •  Preparation of OQ/System and UAT test scripts
  • Coordination of testing, including evaluation of test results; oversees and reviews
  • Validation area processes and procedures.
  • Compilation and quality review of validation binders
  • Preparation of validation summary reports
  • Document activities and work according to SOPs.  Writes clearly and accurately 
  •  Coordinate all validation activities by constant communication with affected departments and personnel;

 

Qualifications

 

  • Minimum of 3 to 5 years years computer system validation experience in Pharmaceutical industry; three years desirable.
  • BS Degree with experience in validation and software development lifecycles, GXPs, 21 CFR Part 11.
  • Excellent written and verbal communication skills.
  • Experience in a regulated environment, especially pharmaceutical (21 CFR Part 11),
  • Good time management and organization skills; the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work 1  

 

 Regards,
 
 Kalpana Sajeev
 Technical Recruiter
 399 Thornall Street 4th Floor
 Edison, NJ  08837
 Desk:   (732) 906-5660 Ext. 235
 Cell:     (732) 822 9539
 Fax:      (732) 906-7688
 

 

MIS Ntwk Assoc Mtg Dates:
Feb 9th Combined Dinner Mtg AWC - Rod Colon - Empowering Today's Professionals (ETP) Network
Feb 16th - Tues - Bring 20 copies of your resume - 6 pm - Carnevale Center 10 Lenox Ave Pompton Lakes 07442 Rm 9 - plan to have dinner with us afterwards

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