Senior Clinical Computer System Validation Engineer

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

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

• Offer quality oversight for software implementation, integration, and data migration efforts.

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

• Ensure that migration and integration processes uphold data integrity, traceability, and compliance with regulations.

• Collaborate with business, IT, data, and quality stakeholders to facilitate project execution and readiness for inspections.

• Review vendor documentation and evaluate supplier validation methodologies.

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

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

• Take charge of software development and engineering outputs, leveraging expertise to tackle complex challenges.

⛳️ 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.

• Strong understanding of GxP, GAMP 5, CSA, 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+).

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

• Experience with system decommissioning, archival processes, and record retention standards.

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

• Demonstrated ability to function effectively in cross-functional and global project teams.

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and clear career pathways.

• Reasonable accommodations during the recruitment process.