10 Month FTC - Senior Computer System Validation Engineer

10 Month FTC - Senior Computer System Validation Engineer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

CSV Quality Consultant to support a strategic software integration program within a regulated pharmaceutical environment. The consultant will provide quality and validation expertise throughout the lifecycle of computerized systems, ensuring compliance with GxP requirements, data integrity principles, and company quality standards.

Key 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.

• Qualifications & Experience

• 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.