Computer Software Validation Specialist

Location: East of Pittsburgh, PA

Job Type: Contract

In a highly regulated environment, the CSV Specialist provides technical subject matter expertise for software testing and validation of computer systems and IT infrastructure. This opportunity is to provide validation services for IT Infrastructure, COTS Laboratory Computer Systems, & Spreadsheets


  • Document authoring activities:
    • Update or create, application/software/IT validation planning documents
    • Update or create, application/software/IT Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents/protocols
  • Review a spectrum of documents (plans, requirements, specifications, configuration, risk, verification, qualification) and assess compliance to FDA regulations and alignment with ISPE GAMP best practices per GPGs prior to approval
  • Execute and contemporaneously report on IQ, OQ, and PQ protocols
  • Coordinate document authoring and execution activities with both internal staff and external consultants
  • Coordinate document approval activities with Company’s Quality Assurance
  • Perform day-to-day activities within the guidance of Standard Operating Procedures (SOPs)
  • Must maintain company quality and safety standards
  • Must maintain company values

Education & Experience:

  • Ability to demonstrate excellent interpersonal and communication skills, both written and verbal
  • A Bachelor’s degree a technology related field of study and/or direct applicable experience with computer systems testing/validation
  • 7+ years of experience in directly executing computer systems validation activities in the biopharma, pharma, or medical device industries
  • As part of the 7+ years of experience, that with both:
    • IT Infrastructure
    • COTS Computer Systems
  • Able to demonstrate the ability to independently carry out tasks under the direction of Company’s CSV staff
  • Ability to demonstrate knowledge of data governance best practices
  • Able to demonstrate a detailed understanding of FDA cGMP quality system principles
  • Ability to demonstrate problem-solving skills and ability to work in both collaborative and independent work situations
  • Able to demonstrate an understanding of FDA 21 CFR Part 11 and related regulations associated with biopharma, pharma, or medical device industries
  • Able to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations relating to them
  • Ability to work under specific time constraints