Software Validation Senior Associate

Pharmaron • Exton, PA

7d • $75,000 - $85,000 • Onsite

About The Position

Pharmaron is seeking a Software Validation Senior Associate to support its GxP laboratories. This role involves leading software validation initiatives to ensure regulatory compliance, system reliability, and operational excellence. The associate will manage the complete software validation lifecycle, partnering with laboratory operations, Quality, IT, and system owners to validate computerized systems used in pharmaceutical and biotechnology research and development. This is a highly visible role for someone looking to combine technical expertise, project management, and regulatory compliance in a collaborative, science-driven environment.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience).
• Minimum of 3 years of Computerized Systems Validation (CSV) experience within pharmaceutical, biotechnology, CRO, or other regulated GxP environments.
• Hands-on experience developing, executing, and documenting validation protocols and software qualification activities.
• Strong project management experience leading multiple validation initiatives simultaneously.
• Experience preparing and maintaining SDLC validation documentation including URS, Functional Specifications, Design Specifications, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Reports.
• Working knowledge of ERP, laboratory software, and computerized systems used in regulated environments.
• Excellent technical writing, documentation, and communication skills.
• Strong organizational, analytical, and problem-solving abilities.
• Experience supporting FDA, client, or international regulatory inspections.
• Experience validating laboratory systems, analytical instruments, LIMS, CDS, ELN, or other GxP computerized systems.
• Knowledge of software implementation, system upgrades, and change management processes.
• Computerized Systems Validation (CSV)
• GAMP 5
• ICH Guidelines
• FDA 21 CFR Part 11
• 21 CFR Parts 58, 210, and 211
• Risk-based validation methodologies
• GxP compliance requirements
• Quality Systems and Change Control processes

Responsibilities

• Lead and support Computerized Systems Validation (CSV) projects from initiation through completion, ensuring compliance with FDA, GAMP, ICH, and global regulatory expectations.
• Lead the full Computerized Systems Validation (CSV) lifecycle for GxP laboratory software and computerized systems.
• Develop validation strategies, validation plans, risk assessments, protocols, reports, and supporting documentation.
• Author and execute Software Development Life Cycle (SDLC) documentation including: User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Traceability Matrices, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
• Partner with system owners and cross-functional teams to develop compliant validation documentation and implementation plans.
• Define project scope, timelines, milestones, deliverables, and resource requirements for CSV initiatives.
• Track project progress, facilitate status meetings, and provide regular updates to leadership.
• Support software implementations, upgrades, system enhancements, and change controls while ensuring continued GxP compliance.
• Review existing validation documentation, identify compliance gaps, and execute remediation plans.
• Author and maintain Quality System documentation including SOPs, Change Controls, CAPAs, and validation procedures.
• Serve as a subject matter expert during internal and external regulatory inspections.
• Monitor evolving FDA, GAMP, ICH, USP, and global regulatory requirements to maintain an effective validation program.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Senior