DEVOPS ENGINEER

Delisi's - San Jose, CA

Full-time - Mid Level

San Jose, CA

About the position

This position is for an experienced software developer in the Information Technology/Data Science industry, focusing on software development life cycles and validation processes. The role requires a strong understanding of various development methodologies and compliance with regulatory standards, particularly in the context of electronic records and signatures.

Responsibilities

• Prepare and review Test Plans and Validation protocols including IQ, OQ, and PQ.
• Conduct High-level Risk Assessments (HLRA) and document findings according to GAMP 5 guidelines.
• Ensure compliance with 21 CFR Part 11 GxP requirements regarding electronic records and signatures.
• Develop and maintain documentation for system validation strategies and reports.

Requirements

• Bachelor's degree or equivalent in computer science, technology, engineering, or a related technical field.
• 2+ years of experience in Software Development Life Cycle (SDLC) including Waterfall, V-shape, and Agile models.
• Experience in preparing and reviewing Test Plans and Validation protocols.
• 2+ years of experience with 21 CFR Part 11 GxP requirements and system validation documentation.

Nice-to-haves

• Strong knowledge in Deviation resolution including Root Cause Analysis and CAPA closeouts.
• Experience with HTML, CSS, Drupal CMS, Axway Track & Trace, and SAP AJTP.