Senior CSV Lead – GxP Lab Software Validation

Pharmaron Beijing Co. Ltd.; West Whiteland Township (Chester County); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Plan

Paid Time Off & Holidays

Health Savings Account (HSA)

Job summary

Pharmaron Beijing Co. Ltd. is seeking a Software Validation Senior Associate in Exton, PA to lead Computerized Systems Validation (CSV) for GxP laboratory software.

You will own validation lifecycle activities, collaborate with Quality, IT, and operations, and ensure regulatory compliance across FDA, GAMP, ICH, and 21 CFR standards. The role emphasizes project leadership, rigorous documentation, and timely delivery of validation plans, protocols, and reports in a fast-paced, science-driven

Qualifications

• Experience with CSV in regulated environments and document control.
• Strong written and verbal communication for validation reporting.
• Proven ability to manage multiple validation initiatives.
• Working knowledge of SDLC validation documentation.

Responsibilities

• Lead the CSV lifecycle for GxP laboratory software and systems.
• Develop validation strategies, plans, risk assessments, protocols, and reports.
• Author and execute URS, FDS, IQ/OQ/PQ, and traceability matrices.
• Collaborate with system owners and cross-functional teams on validation plans.
• Define scope, timelines, milestones, and resources for CSV projects.
• Track progress and provide updates to leadership; support change controls.
• Maintain Quality System docs and support regulatory inspections.

Skills

CSV

Regulatory compliance

Project management

SDLC documentation

GxP environments

Technical writing

Education

Bachelors in CS/Engineering/Life Sciences

Tools

ERP

LIMS

CDS

ELN

Job description

Pharmaron Beijing Co. Ltd. is seeking a Software Validation Senior Associate in Exton, PA to lead Computerized Systems Validation (CSV) for GxP laboratory software.

You will own validation lifecycle activities, collaborate with Quality, IT, and operations, and ensure regulatory compliance across FDA, GAMP, ICH, and 21 CFR standards. The role emphasizes project leadership, rigorous documentation, and timely delivery of validation plans, protocols, and reports in a fast-paced, science-driven