Description

You will manage computer system validation for EMS and BMS applications within an Agile environment.

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 based on project type and category within the SDLC.
• Execute and review test scripts, test execution, and defect management.
• Apply FDA guidance, industry standards such as GAMP, and 21 CFR Part 11 using a risk-based approach.
• Manage multiple parallel releases and ensure adherence to procedures, work instructions, and templates.

Required Skills

• 7-10 years of experience in Computer System Validation (CSV) of EMS and BMS applications.
• Extensive knowledge of CSV auditing and documentation creation/revision.
• Practical experience with 21 CFR Part 11 and Risk Based Approach.
• Deep understanding of the Software Development Life Cycle (SDLC).
• Proficiency with Jira and QTest.
• Experience with ServiceNow or change control/management systems.
• Experience with Bitbucket or similar code repositories.
• Hands-on experience with automated test tools.
• Project management experience within Agile methodologies.

Preferred Skills

• Experience with tool validation for ServiceNow or automation tools.

Key Skills

Education

Any Gradute