Senior Clinical Computer System Validation Engineer
On-siteBlue Bell, Pennsylvania, United States
Job Summary
Support the validation lifecycle of computerized systems in accordance with GAMP 5, CSA, and internal quality procedures. Provide quality oversight for software implementation, integration, and data migration activities. Develop and review validation deliverables, including validation plans, risk assessments, requirements traceability matrices, test protocols, summary reports, and change controls. Ensure migration and integration activities maintain data integrity, traceability, and regulatory compliance. Partner with business, IT, data, and quality stakeholders to support project delivery and inspection readiness. Review vendor documentation and assess supplier validation approaches. Lead or support computerized system retirement and decommissioning activities, including archival, data retention, and preservation of validation evidence. Identify compliance risks and recommend pragmatic, risk-based solutions.
Required Qualifications
- Bachelor's degree in Life Sciences, Computer Science, Engineering, Information Technology, or a related discipline
- Minimum 10 years of experience in Computerized System Validation (CSV) within the pharmaceutical, biotechnology, or medical device industry
- Strong knowledge of GxP, GAMP 5, CSA, 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+)
- Proven experience supporting system implementations, integrations, and data migration projects
- Experience with system decommissioning, archival, and record retention requirements
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Desired Qualifications
- Excellent stakeholder management, communication, and problem-solving skills
- Demonstrated ability to work in cross-functional and global project teams
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.