Validation Engineer

Job Role: Validation Engineer

Location: Palo Alto, CA

Contract: W2

Job Description:

6+ years of experience as a Validation Engineer.

4+ years of experience with Labware LIMS, LabX, etc.

Plan, lead, and executed the validation efforts for standalone Lab Instrument Software systems.

Responsible for planning, scheduling, and executing validation efforts for LabX and other pharmaceutical systems.

Ensures validation is being performed per established procedure, reviews validation documentation, and coordinates between direct groups for the same.,

Identify intended use of laboratory instruments, develop qualification deliverables per current procedure and standards, and coordinate validation activities between vendors, cross-functional teams and users.

Communicate to different stakeholders and management on the progress of validation efforts

Work with the project team to identify the activities of the project, and dependencies, and figure out future enhancements.

Thorough understanding of FDA and EU guidelines for validation including GAMP, Data Integrity, and ASQ

Hands-on working knowledge of Trackwise, Veeva Vault, and other compliance systems.

Execute protocols or peer review protocols depending on the level of access required for execution.

Support the routing and accurate documentation of all Change Management, Deviation, and Corrective Actions Preventative Actions (CAPAs).

Assist in Performing Risk and Impact assessment for validation activities and change requests.

Support Data Integrity Assurance Program for all documentation managed by their team.