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Hired by Matrix

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Computer System Validation (CSV) Engineer

Myerstown, PA · On-site

$65/hr

  • Medical

  • Dental

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.

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Computer System Validation (CSV) Engineer

Hired by Matrix

Myerstown, PA • On-site

$65/hr

Contractor

Medical, Dental

Posted 5 days ago

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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