Description

You will manage the validation of operational technology tools and SAP application implementations.

This role is on-site.

Responsibilities

• Draft and approve CSV deliverables including Compliance Analysis, Compliance Plans, Test Protocols, Test Reports, and Compliance Summary Reports.
• Guide project teams on applicable deliverables and SDLC requirements based on project type and category.
• Execute and review test scripts, test execution, and defect management for SAP implementations.
• Apply FDA guidance, industry standards like GAMP, and 21 CFR Part 11 using a risk-based approach.
• Manage multiple parallel releases within an Agile methodology.

Required Skills

• 7+ years of experience in Computer System Validation (CSV).
• 5+ years of experience validating SAP application implementations.
• Extensive knowledge of CSV auditing and documentation creation/revision.
• Proficiency with ServiceNow, Jira, and QTest.
• Solid understanding of SDLC and change control management systems.
• Experience with automated test tools and Bitbucket code repositories.
• Working knowledge of Agile methodologies.

Preferred Skills

• Experience with ServiceNow Operational Technology tool validation.
• Experience with automation tools.

Key Skills

Education

Any Graduate