Senior Clinical Computer System Validation Engineer

This is a fully remote position, open to applicants in Ireland, +4 more states.

📋 Description

• Assist in the validation lifecycle of computerized systems following GAMP 5, CSA guidelines, and internal quality protocols.

• Offer quality oversight during software implementation, integration, and data migration processes.

• Create and evaluate validation deliverables, including validation plans, risk assessments, requirements traceability matrices, test protocols, summary reports, and change controls.

• Ensure that data integrity, traceability, and regulatory compliance are upheld during migration and integration efforts.

• Collaborate with business, IT, data, and quality stakeholders to facilitate project delivery and ensure inspection readiness.

• Assess vendor documentation and evaluate supplier validation methodologies.

• Lead or assist in the retirement and decommissioning of computerized systems, which involves archival, data retention, and preservation of validation evidence.

• Identify compliance risks and suggest practical, risk-based solutions.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Computer Science, Engineering, Information Technology, or a related field.

• At least 10 years of experience in Computerized System Validation (CSV) within the pharmaceutical, biotechnology, or medical device sectors.

• In-depth knowledge of GxP, GAMP 5, CSA, 21 CFR Part 11, Annex 11, and principles of data integrity (ALCOA+).

• Proven track record in supporting system implementations, integrations, and data migration initiatives.

• Familiarity with system decommissioning, archival, and record retention specifications.

• Exceptional skills in stakeholder management, communication, and problem-solving.

• Demonstrated capability to work within cross-functional and global project teams.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage when applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Reasonable accommodations available throughout the recruitment process.