72 . Test Engineer - Santa Clara , California 95054 TEMP  -  
 
           
Job Number: 67278 WVSG is looking to hire a Validation Engineer for our client.
Posted on: 02/22/2013
Pay $: 50.00
       
     
 
    Category:     Contract  
 
    Description:    

The job is a mid-level position working with our standard software package. The validation group is responsible for all aspects of validating our standard software platform including hotfixes, new releases, and customizations. We host FATs and work with the customer to execute our standard FAT as well as provide support throughout SAT and IOQ. 

Responsibilities:

  • Assist with writing, reviewing and executing customer FATs, SATs and IOQs for a highly customizable software package. Completed under the direction of the Validation Manager
  • Assist with writing validation tests for software customizations requested by customers. In general, this work is completed under an accelerated timeline
  • Help develop and maintain SOPs
  • Write validation summary reports
  • Interact closely with customers for FATs
  • Perform documentation reviews of software FRSs and DDSs
  • Some local or possibly international travel may be required, but will be minimal (<10%)
 
 
    Qualifications:    

Requirements:

  • BS/BA Degree. Preferably a Scientific or Engineering degree
  • Minimum of 5 years? experience in validation work, preferably biotech or pharmaceutical
  • Validation experience: hands-on experience with the development and execution of FATs, SATs and IQ/OQs
  • Strong knowledge of 21 CFR Part 11, GAMP, audit trails, security features, cGMP, GDP and regulatory requirements for automated systems
  • Self-motivated and capable of adhering to strict deadlines is a must
  • Highly effective verbal and written skills, including technical writing, are a must
  • Ability to adapt the validation model in a rapidly changing environment
  • Flexibility to multi-task and develop innovative solutions
  • Experience with DeltaV is required
  • Experience with Automated Process Control Systems (preferably DeltaV) is highly beneficial
  • Experience writing RTMs, Risk Assessments and Gap Analysis is highly favorable
  • Knowledge of VB or C#.NET Framework is a plus
  • Experience with HW/SW interactions is valuable
  • Familiarity with European, Asian (China, India, Korea, Japan), or South American (Brazil, Argentina) validation practices is helpful
 
 
    Contact:     Raymond Soto
390 Potrero Avenue
Sunnyvale ,  California    94085
(408) 735-1420 ext. 3028
rsoto@westvalley.com
 
 
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