Job description – Computer System Validation Engineer

The Computer System Validation (CSV) Engineer will be the functional lead for establishment and documented evidence through formal assessment, specification, testing, and reporting providing a high degree of assurance that critical GxP computerized systems meet design criteria/specifications for intended use and perform as intended. Ensures adequate measures are in place to achieve and maintain GxP compliance through all lifecycle stages from inception to retirement.
 

DUTIES AND RESPONSIBILITIES:
The Computer System Validation Engineer will lead efforts to generate documentation which meets regulatory and industry standard guidelines in a timely and efficient manner in a challenging and fast moving environment. These documents include but are not limited to; User Requirement Specifications, Functional Requirement Specifications, Validation Plans, design / configuration specifications, traceability matrix, design qualification, IOQPQ protocols and summary reports, regression testing, data migration testing, supplier assessments, risk assessments, 21 CFR Part 11 assessments, as well as manage the site computerized systems inventory and overall critical GxP computer system lifecycle management.

  • Assist with development and validation of spreadsheets
  • May be required to work off-shift or weekends to support validation efforts.
  • Able to work well in a team oriented environment.
  • Be flexible, proficient in technical writing, strong interpersonal and communication skills.
  • Demonstrated relationship, team building skills and able to encounter challenges
  • Assist or manage implementation of critical computerized systems.
  • Efficient in Microsoft® Office and other software as applicable.
  • Advanced understanding of the authoring of protocols and exceptions, discrepancies, deviation issue resolution.

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Required: Minimum of A.A.S. degree in Computer Science or equivalent
  • Preferred: Bachelor’s degree in Computer Science/Engineering or equivalent
  • Required: 2-3 years’ experience in a GxP environment working with critical computerized system validation.
  • Preferred: 3+ years’ experience in a GxP environment working with critical computerized system validation.

 

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