14 days old
2018-01-052018-02-02

Computer Systems Validation Engineer

Menlo Park, CA 94025
  • Job Code
    591919
  • Payrate
    $50 To $55

Validation Engineer


Menlo Park, CA


Computerized systems validation (CSV) project in an FDA-regulated environment.


Responsibilities:



  • Write Validation Protocols such as IQ, OQ and PQs
  • Execute Validation Protocols such as IQ, OQ and PQs to ensure compliance and adherence with applicable guidelines
  • Excel Spreadsheet Generation and Summary Report Writing for PQ studies
  • Review and modify Standard Operating Procedures (SOPs)
  • Generate test procedures to validate new or previously unvalidated processes
  • Write risks assessments and applicable test scripts according to GLP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
  • Prepare validation summary reports for executed protocols.
  • Communicate Computer System Validation approaches and requirements during planning/audits.


Requirements:



  • Experience drafting and executing validation documents
  • Recent experience doing product serialization
  • Minimum Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.), Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy, etc.)
  • Self-starter
  • Computer System Validation (CSV), 21 CFR Part 11 regulation/ EU regulations experience
  • Leadership experience is a plus
  • Interested in making a contribution to the company while learning
  • Interested in learning validation and other activities required for companies to be compliant with Food and Drug Administration (FDA) regulations
  • Strong communication and interpersonal skills

Categories

  • Information Technology

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Computer Systems Validation Engineer

Randstad Technologies
Menlo Park, CA 94025

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Randstad Technologies
Menlo Park, CA
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