Job Description

Job Description

Job Description

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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