At-a-Glance:

\nAre you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Computer System Validation (CSV) Engineer.\n

Position Type:

\nContract\nOnsite\n

Required:

\nBachelor's in Life Sciences, Engineering, or Computer Science\n7 years of CSV experience in a regulated pharma or life sciences environment\nHands-on validation experience with LIMS, ERP, or MES systems\nStrong knowledge of

GAMP 5, 21 CFR

Part 11, and EU Annex 11\nAbility to author complete, inspection-ready validation packages independently\nExperience conducting and documenting formal risk assessments\n

Preferences:

\nExperience validating cloud-based or SaaS systems under GAMP 5 Category 4/5\nFamiliarity with Veeva Vault, Kneat, or similar electronic validation platforms\nPrior experience supporting FDA or EMA inspections in a CSV capacity\nBackground in biologics, clinical manufacturing, or combination products\n

Responsibilities:

\nOwn the validation lifecycle for GxP-regulated computer systems\nWork directly with quality, IT, and manufacturing teams to deliver compliant, audit-ready validation packages\nLead end-to-end validation of LIMS, ERP, and MES systems per 21 CFR Part 11 and GxP regulations\nAuthor, execute, and review URS, FS, Validation Plans, IQ/OQ/PQ protocols, and Summary Reports\nManage periodic reviews and revalidation of existing validated systems\nCoordinate with system owners, vendors, and IT to define scope, timelines, and deliverables\nApply GAMP 5 principles to classify systems and define risk-based validation strategies\nConduct formal risk assessments including FMEA and maintain site-level risk registers\nEnsure risk controls are reflected in validation test scripts and traceability matrices\nAssess computerized systems for data integrity compliance including audit trails, access controls, and electronic records\nEvaluate and remediate 21 CFR Part 11 gaps in existing validated systems\nSupport data integrity investigations and respond to related audit findings\nServe as CSV SME during FDA, EMA, and client audits and inspections\nAuthor and maintain SOPs, deviations, change controls, and CAPAs for validated systems\nStay current with 21 CFR Part 11, EU Annex 11, ICH Q9, and

USP 1058

guidance\nGet in

Touch:

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