Senior Clinical Computer System Validation Engineer

ICON plc • Lisbon, MA

12h • Remote

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are seeking an experienced 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.

Requirements

• 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.

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.

Benefits

• Competitive base salary and 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior