Software Validation Senior Associate

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

Position

Software Validation Senior Associate

Salary Range

$75,000-$85,000

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 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.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

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

If you're looking for an opportunity to combine technical expertise, project management, and regulatory compliance in a collaborative, science-driven environment, we'd love to hear from you.

As a Software Validation Senior Associate, you'll 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 We're Looking For

• 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

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 25,000 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

• 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

As an Equal Employment Opportunity and Aff...

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D 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 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Aff...