Computer Systems Validation Specialist

Madison-Davis, LLC; Bridgewater Township (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Madison-Davis, LLC is seeking an experienced Computer Systems Validation Specialist to lead CSV strategy and validation documentation for business-application implementations and ongoing system changes. You will coordinate validation activities and ensure compliance with GxP and regulatory requirements.

The role requires hands-on CSV experience, strong technical writing, and the ability to collaborate with IT, QA, and business owners to maintain compliant computerized systems.

Qualifications

• Bachelor's degree or higher in Computer Science, Engineering, Life Sciences, or related field.
• 5–10 years of CSV experience in a GMP/GxP environment.
• Hands-on validation experience including IQ/OQ/PQ.
• Strong technical writing and documentation skills.

Responsibilities

• Develop risk-based CSV strategies for new implementations and existing system changes.
• Author Validation Plans, Validation Summary Reports, and other validation deliverables.
• Collaborate on functional requirements, specifications, and IQ/OQ/PQ documentation.
• Coordinate CSV deliverables across concurrent implementation projects.
• Provide guidance during test execution and review protocols.
• Maintain and route validation documentation through Veeva approval workflows.
• Ensure systems comply with GxP regulations and internal standards.
• Partner with IT, QA, and business system owners to support validation.

Skills

CSV strategy

Technical writing

Project coordination

GxP compliance

Veeva

Risk-based approach

Stakeholder communication

Education

Bachelor's degree

Tools

Veeva systems

IQ/OQ/PQ

GAMP 5

Job description

A biopharmaceutical organization is seeking an experienced Computer Systems Validation Specialist to support business-application implementation projects and ongoing system changes. This position will provide CSV strategy, validation documentation leadership, and project-level coordination to ensure computerized systems are implemented and maintained in accordance with regulatory and quality requirements. The ideal candidate will bring hands-on validation experience, strong technical writing skills, independent judgment, and a practical risk-based approach to computerized-system compliance.

RESPONSIBILITIES

• Develop risk-based CSV strategies for new implementations and existing system changes.
• Author Validation Plans, Validation Summary Reports, and other key validation deliverables.
• Collaborate on functional requirements, specifications, and IQ/OQ/PQ documentation.
• Coordinate CSV deliverables across concurrent implementation projects.
• Provide guidance during test execution and review executed protocols.
• Maintain and route validation documentation through Veeva approval workflows.
• Ensure computerized systems remain compliant with applicable GxP regulations and internal standards.
• Partner with IT, QA, and business system owners to support successful system validation.

Role Requirements

• Approximately 5 to 10 years of relevant Computer Systems Validation experience.
• Hands-on experience supporting GxP computerized-system validation.
• Strong authorship experience with Validation Plans and Summary Reports.
• Ability to develop and execute risk-based CSV strategies.
• Experience validating software implementations and system enhancements.
• Experience with Veeva systems and validation processes.
• Understanding of GAMP 5, Category 5 systems, 21 CFR Part 11, Annex 11, and relevant GxP requirements.
• Familiarity with Computer Software Assurance, data integrity, and IQ/OQ/PQ processes.
• Strong technical writing, project coordination, and stakeholder communication skills.
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.

PREFERRED EXPERIENCE

• Experience with AI application validation or qualification.
• Experience assessing GxP implications of AI-related use cases.
• Exposure to additional Veeva business applications and training-related systems.