Senior Clinical Computer System Validation Engineer
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.
What You Will Do:You will take ownership of software development and engineering deliverables, applying your expertise to complex challenges.
Key responsibilities include:
- 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.
Your Profile:- 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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
