Software Validation Senior Associate

Position: Software Validation Senior Associate

Salary Range: $75000-$85000

Location: Exton PA (Onsite)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25000 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.

Were proud of the impact we make and just last year we supported 887 discovery projects 1100 CMC programs and 1397 clinical trials across all phases. Our teams are involved in everything from small molecules ADCs biologics and gene therapies and we work with more than 3300 global customers. To learn more visit .

What Youll Do

Are you an experienced Computerized Systems Validation (CSV) professional with a passion for quality compliance and project leadership Were 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 youll 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.

If youre looking for an opportunity to combine technical expertise project management and regulatory compliance in a collaborative science-driven environment wed love to hear from you.

As a Software Validation Senior Associate youll lead and support Computerized Systems Validation (CSV) projects from initiation through completion while ensuring compliance with FDA GAMP ICH and global regulatory expectations.

Key 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.

What Were Looking For

• Bachelors 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

Why Pharmaron

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004 Pharmaron has invested in its people and facilities and established a broad spectrum of research development and manufacturing service capabilities throughout the entire drug discovery preclinical and clinical development process across multiple therapeutic modalities including small molecules biologics and CGT products. With over 25000 employees and operations in the US UK China and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America Europe Japan and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment where teamwork and innovation go hand in hand. Here your voice matters and your contributions make a real impact. Employees Number One and Clients Centered are the core cultural values at Pharmaron. Our culture which sets Pharmaron apart from other organizations has evolved from our deep commitment to our employees partners and collaborators.

Benefits: As part of our commitment to your well-being we offer a comprehensive benefits package:

• 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

How to Apply:

Ready to seize this incredible opportunity Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer Pharmaron values diversity and inclusion in the workplace fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

#LI-PR1

Required Experience:

Senior IC