Software Validation Associate

Pharmaron

10d • Onsite

About The Position

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.

Requirements

• 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

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

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
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees