Note: The job is a remote job and is open to candidates in USA. ICON plc is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster. The Senior Clinical Computer System Validation Engineer will provide quality and validation expertise for computerized systems throughout their lifecycle in a regulated pharmaceutical environment, ensuring compliance with GxP requirements, data integrity principles, and company quality standards. The role supports software implementation, integration, data migration, validation deliverables, stakeholder collaboration, and system decommissioning.
Responsibilities
- 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, 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
Skills
- 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
- Excellent stakeholder management, communication, and problem-solving skills
- Demonstrated ability to work in cross-functional and global project teams
Benefits
- Performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Company Overview