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Position: Software Validation Associate

Salary Range: $48k - $50k

Location: Exton, PA

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 21,000 employees worldwide across 23 locations in the US, UK and China, 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 over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ 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 3,000 global customers. To learn more, visit www.pharmaron.com.

Job Overview:

Pharmaron is seeking a motivated and detail-oriented Software Validation Associate to join our team in Exton, PA. This role offers an exciting opportunity to build expertise in Computerized Systems Validation (CSV) while supporting critical laboratory systems that enable the development of life-changing therapies.

As a Software Validation Associate, you will collaborate with Quality, IT, laboratory operations, and system owners to ensure computerized systems and software applications meet regulatory requirements and industry best practices. You will actively participate in all phases of the validation lifecycle, including risk assessments, validation planning, protocol execution, documentation development, and compliance assessments for GMP and GLP laboratory environments.

Key Responsibilities

• Support and execute computerized system validation activities throughout the entire system lifecycle for laboratory software and related technologies.
• Develop, review, and execute validation documentation including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications, IQ/OQ/PQ protocols, Traceability Matrices, and final reports.
• Collaborate cross-functionally with laboratory personnel, Quality Assurance, IT, and system owners to ensure validated systems meet regulatory and business requirements.
• Participate in risk assessments and identify opportunities to improve validation processes and compliance practices.
• Review existing validation documentation, identify compliance gaps, and assist in implementing remediation plans when necessary.
• Ensure computerized systems remain compliant with applicable regulations and guidance, including GAMP, ICH, USP, ALCOA+, and 21 CFR Part 11.
• Support software implementation, upgrades, change controls, and periodic reviews within regulated laboratory environments.

What We're Looking For

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, Engineering, or a related discipline.
• Foundational knowledge of GMP, GLP, GAMP, ICH guidelines, and 21 CFR Part 11 requirements.
• Experience with software validation, software testing, database integration, or computerized systems in a regulated environment through industry experience, internships, or academic projects.
• Understanding of Software Development Life Cycle (SDLC) principles and validation methodologies.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication skills and the ability to collaborate effectively across multiple functions.
• A strong attention to detail and commitment to quality and compliance.

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 21,000 employees and operations in the U.S., the U.K. and China. 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:

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

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.

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