Software Validation Senior Associate

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services. Last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams work with small molecules, ADCs, biologics, and gene therapies for more than 3,300 global customers.

About the role

We're seeking a Software Validation Senior Associate to support our GxP laboratories by leading software validation initiatives that ensure regulatory compliance, system reliability, and operational excellence. In this highly visible role, you'll manage the complete software validation lifecycle while partnering with laboratory operations, Quality, IT, and system owners to validate computerized systems supporting pharmaceutical and biotechnology research and development.

Responsibilities

• 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.

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.
• 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.

Skills

• 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
• Excellent technical writing, documentation, and communication skills
• Strong organizational, analytical, and problem-solving abilities

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
• 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

Pay

$75,000-$85,000

Schedule

Onsite (Exton, PA)