Computer System Validation (CSV) Engineer

Hired by Matrix

Job Description

At-a-Glance:
Are 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.

Position Type:

Contract
Onsite

Required:

Bachelor's in Life Sciences, Engineering, or Computer Science
7 years of CSV experience in a regulated pharma or life sciences environment
Hands-on validation experience with LIMS, ERP, or MES systems
Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11
Ability to author complete, inspection-ready validation packages independently
Experience conducting and documenting formal risk assessments

Preferences:

Experience validating cloud-based or SaaS systems under GAMP 5 Category 4/5
Familiarity with Veeva Vault, Kneat, or similar electronic validation platforms
Prior experience supporting FDA or EMA inspections in a CSV capacity
Background in biologics, clinical manufacturing, or combination products

Responsibilities:

Own the validation lifecycle for GxP-regulated computer systems
Work directly with quality, IT, and manufacturing teams to deliver compliant, audit-ready validation packages
Lead end-to-end validation of LIMS, ERP, and MES systems per 21 CFR Part 11 and GxP regulations
Author, execute, and review URS, FS, Validation Plans, IQ/OQ/PQ protocols, and Summary Reports
Manage periodic reviews and revalidation of existing validated systems
Coordinate with system owners, vendors, and IT to define scope, timelines, and deliverables
Apply GAMP 5 principles to classify systems and define risk-based validation strategies
Conduct formal risk assessments including FMEA and maintain site-level risk registers
Ensure risk controls are reflected in validation test scripts and traceability matrices
Assess computerized systems for data integrity compliance including audit trails, access controls, and electronic records
Evaluate and remediate 21 CFR Part 11 gaps in existing validated systems
Support data integrity investigations and respond to related audit findings
Serve as CSV SME during FDA, EMA, and client audits and inspections
Author and maintain SOPs, deviations, change controls, and CAPAs for validated systems
Stay current with 21 CFR Part 11, EU Annex 11, ICH Q9, and USP 1058 guidance

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Vacancy posted 2 days ago

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