Computer System Validation Engineer

Responsibilities

• Experience in validating laboratory and labeling systems.
• 5+ years’ experience with System Development Lifecycle and 10+ years’ experience in Computer System Validation (based on the role selected).
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and risk based validation.
• Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., requirements, compliance plans, test protocols, test summary reports, and compliance reports).
• Experience in reviewing system test and user acceptance test scripts, defect management, traceability matrix and design specs; experience in QA methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures.
• Preferred tools knowledge and experience: JIRA, QTest, Service Now, XRAY and change record review.
• Technology quality representative and provide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide validation guidance, timely reviews, and escalations to TQ management.

7‑9 years.

Bachelor of Technology/Engineering.

Information Security – Regulatory Compliance Management – Life Sciences (GXP FDA CSV IQ/OQ/PQ).