CSV Engineer
Job Title: CSV Engineer
Location: Hybrid Pittsburgh, PA
Duration: 6 Months
Experience: 5 - 8
Overview:
We're looking for an experienced Computer System Validation (CSV) Engineer to support a 6-month contract at a leading pharmaceutical site in Pittsburgh. You'll validate critical GxP computerized systems-including CMMS, BAS, SCMS, and EMS-used in GMP manufacturing. This role requires hands-on validation work and cross-functional collaboration with QA, IT, Engineering, Facilities, and CQV teams.
Key Responsibilities:
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Prepare and execute validation deliverables: URS, Risk Assessments, IQ/OQ/PQ, Validation Plans, and Summary Reports
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Validate systems like CMMS (e.g., BMRAM), BAS, EMS, and SCMS
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Ensure compliance with GAMP 5, ALCOA+, 21 CFR Part 11, and EU Annex 11
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Work across departments to maintain validation traceability and readiness
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Support change controls, deviations, and impact assessments for validated systems
Required Qualifications:
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5 8 years of CSV experience in a pharma or biotech environment
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Strong knowledge of GAMP 5 and 21 CFR Part 11
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Experience authoring and executing validation protocols
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Hands-on work with GxP systems in a GMP manufacturing setting
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Prior use of Kneat or other electronic validation platforms is a plus
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Background in sterile manufacturing or CGT environments is preferred
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