Senior CSV Validation Specialist – Onsite in PA

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

Benefits offered by this job

Medical Insurance

401(k)

Paid Time Off

HSA Contributions

Life Insurance

EAP

Career growth

Job summary

Pharmaron is seeking a Software Validation Senior Associate in Exton, PA to lead CSV efforts for GxP laboratory software and systems. You will develop validation plans, risk assessments, and regulatory documentation, collaborating with Quality, IT and system owners to ensure compliant validation programs.

The role emphasizes project leadership, SDLC documentation, and ongoing validation activities in a fast-paced, regulated environment.

Qualifications

• Requires CV/CSV experience in regulated environments.
• Experience documenting validation protocols and software qualification.
• Strong writing and regulatory communication skills.

Responsibilities

• Lead CSV lifecycle for GxP laboratory software and systems.
• Develop validation strategies, plans, risk assessments, and protocols.
• Prepare URS, FS, IQ/OQ/PQ, and traceability matrices.
• Report progress to leadership and coordinate with cross-functional teams.
• Support validation activities during system upgrades and change controls.

Skills

CSV Lifecycle

Regulatory Compliance

Project Leadership

Technical Writing

GxP Knowledge

FDA 21 CFR Part 11

Pharma IT Systems

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences

Tools

ERP Systems

LIMS/CDMS

Regulatory Documentation Tools

Job description

Pharmaron is seeking a Software Validation Senior Associate in Exton, PA to lead CSV efforts for GxP laboratory software and systems. You will develop validation plans, risk assessments, and regulatory documentation, collaborating with Quality, IT and system owners to ensure compliant validation programs.

The role emphasizes project leadership, SDLC documentation, and ongoing validation activities in a fast-paced, regulated environment.