Senior Clinical Computer System Validation Engineer

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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 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 • Take ownership of software development and engineering deliverables, applying expertise to complex challenges

🎯 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 • Legal right to work in the country where the role is based

🏖️ 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 • Reasonable accommodations during the recruitment process