Software Validation Associate

Position: Software Validation Associate

Salary Range: $70K-$74K

Location: On-Site Germantown, MD

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

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

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.

• 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

• 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, 21
  
  CFR
  11 and 21
  
  CFR
  58
• 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

• 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

As an Equal Employment Opportunity and Affidavit 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.