Job: Validation Analyst

We have multiple positions throughout the US.  Please indicate your preferred location(s).

Mandatory Technical Skills

• Good understanding of Software Development Life Cycle (SDLC) and Validation life cycle
• Experience in formulation of Test Plan, Test Cases and Test
• Scripts for functional, system, integration and regression testing based on the designed document and user requirement specification (URS) document for the functional, security and performance testing.

Desirable Technical Skills

• Understanding on Life Science domain
• Understanding on various regulations GxP, 21CFR Part 11 and others

Mandatory Functional Skills

• Work closely with validation lead to implement the project validation activities.
• Assist the Validation Lead with the authoring Validation deliverable for large projects
• Independently provide guidance and be responsible for validation of small projects
• Responsible for pre-review and post execution review of all the test protocols
• Review of traceability metrics
• Create test summary report
• Ensure library management of all validation deliverables

Responsible for

• updating current state compliance of IT portfolio
• follow-up of the review and approval cycle with Quality, Business and IT Team

Desirable Functional Skills

• Experience in HPQC, Trackwise