Computer System Validation (CSV) Engineer#26-07673 $65 per hour Myerstown, PA Onsite 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 Get in

Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at (201) 478-6913 to learn more. #LI-VK1 #HbM6349