Position: Software Validation Associate

Salary Range: $70K-$74K

Location: On-Site Germantown, MD

Unfortunately, we cannot support work visa permit applications for this role

About Pharmaron

Pharmaron is a global CRO (Contract Research Organization) 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:

The Software Validation Associate is responsible for maintaining the Computer Software Validation (CSV) Program and supporting all validation activities for computerized systems. This role ensures compliance with regulatory requirements while supporting GLP laboratory operations. The ideal candidate will actively participate in validation lifecycle activities, collaborate cross-functionally, and provide technical expertise in software validation processes.

Key Responsibilities:

Lead and support all phases of the computer software validation lifecycle, including planning, risk assessment, protocol/report generation, execution, and data analysis
Develop, review, and maintain validation documentation (e.g., Validation Plans, Risk Assessments, URS, Functional/Design Specifications, IQ/OQ/PQ protocols and reports, SOPs) in collaboration with system and equipment owners
Execute software validation activities aligned with SDLC and ensure compliance with applicable regulatory standards (e.g., GAMP, ICH, USP, 21 CFR Part 11)
Provide compliance guidance for software updates, manage vendor validation documentation, and identify/remediate gaps in existing CSV documentation
Support audits, inspections, and laboratory operations as a Subject Matter Expert, while staying current with evolving regulatory and industry standards

What We're Looking For:

BS or MS degree in information technology, Life Sciences, Engineering or related discipline, or equivalent experience required
One to two years hands-on software validation experience in the biotechnology or pharmaceutical industries including writing, executing, and summarizing validation protocols and testing procedures
Experience working in a GxP Life Sciences environment for Computer Systems Validation (CSV)
Broad and in-depth knowledge of computerized systems and regulatory requirements, and current validation approaches to evaluate computerized systems
Knowledge of global regulatory requirements for validation, including current GAMP, ICH guidelines and USP, 21CFR11 and 21CFR58
Excellent technical writing skills with strong attention to detail
Exceptional written and verbal communication skills
Ability to plan, schedule and execute Validation Lifecycle deliverables
Ability to anticipate problems/issues and create contingency plans
Ability to interact effectively with all levels of personnel within the organization

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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