Software Validation Associate

Pharmaron • Exton, PA

8d • $48,000 - $50,000 • Onsite

About The Position

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.

Requirements

• 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.

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.

Benefits

• 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

What This Job Offers

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