Senior Software Validation Associate – CSV for Pharma

Pharmaron Beijing Co. Ltd.; Exton (PA); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid time off

Employee assistance program

Job summary

Pharmaron Beijing Co. Ltd. is seeking a Software Validation Senior Associate in Exton, PA to lead CSV efforts for laboratory software and systems. You will design validation strategies, plans, and documentation, coordinating with IT, Quality, and system owners to ensure regulatory compliance and lifecycle execution.

The role emphasizes project leadership, SDLC documentation, and strong writing skills to support FDA/GAMP/ICH expectations in a fast-paced, science-driven environment.

Qualifications

• Minimum 3 years of CSV experience in regulated gXP environments.
• Hands-on experience developing, executing, and documenting validation protocols and software qualification activities.
• Experience supporting FDA/ICH/GxP inspections and regulatory expectations.

Responsibilities

• Lead the full CSV lifecycle for GxP laboratory software and systems.
• Develop validation strategies, plans, risk assessments, protocols, and reports.
• Prepare and maintain SDLC validation documentation (URS, FS, DS, IQ/OQ/PQ, TRacE matrices).
• Collaborate with system owners and cross-functional teams to ensure compliant validation documentation.
• Monitor regulatory requirements and drive remediation to maintain GxP compliance.

Skills

CSV experience

Project management

Technical writing

Regulatory compliance

GxP knowledge

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Tools

LIMS

ELN

CDMS

SDLC tooling

Job description

Pharmaron Beijing Co. Ltd. is seeking a Software Validation Senior Associate in Exton, PA to lead CSV efforts for laboratory software and systems. You will design validation strategies, plans, and documentation, coordinating with IT, Quality, and system owners to ensure regulatory compliance and lifecycle execution.

The role emphasizes project leadership, SDLC documentation, and strong writing skills to support FDA/GAMP/ICH expectations in a fast-paced, science-driven environment.