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.