Computer System Validation Specialist Engineer

Pittsburgh, PA
Contracted
Mid Level

GForce is seeking a Computer System Validation Specialist Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Pittsburgh, PA. The CSV Engineer will lead the implementation and validation of computerized maintenance systems-particularly CMMS platforms like Blue Mountain-ensuring compliance with regulatory and data integrity standards.

Responsibilities of the CSV Engineer include:

  • Author, review, and execute validation deliverables including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
  • Support the validation of GxP computerized systems such as CMMS, BAS, EMS, and SCMS, ensuring compliance with regulatory and data integrity standards.
  • Apply GAMP 5 and risk-based validation principles to ensure systems meet 21 CFR Part 11, Annex 11, and ALCOA+ requirements.
  • Collaborate with cross-functional teams including QA, IT, Engineering, and Facilities to drive validation readiness and execution.
  • Manage validation lifecycle activities using Kneat or similar platforms, ensuring traceability, audit readiness, and support for change control and deviation processes.

Qualifications for the CSV Engineer include:

  • 5-8 years of experience in Computer System Validation (CSV) or Computer Software Assurance (CSA) within pharmaceutical, biotech, or other regulated life sciences industries.
  • Proven expertise in qualifying GMP computerized systems such as CMMS, BAS, EMS, and SCMS, with a strong grasp of data integrity and compliance requirements.
  • Thorough understanding of GAMP 5, risk-based validation methodologies, and regulatory frameworks including 21 CFR Part 11 and Annex 11.
  • Skilled in authoring and executing validation protocols, test scripts, and technical documentation, with strong organizational and cross-functional collaboration abilities.
  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline.

Term & Start:

  • Benefits included (Medical, Dental, Vision, 401k)
  • 6 Month Contract with the opportunity to extend
  • 40 Hours Per Week
  • 100% Onsite in Pittsburgh, PA
  • Start Date: As Soon As Possible
  • No Travel
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