Job Description

CSV / Lab Systems Validation Specialist

Type of role: Contract
********Hybrid - must work on site 2 days per week
Duration: 12-36+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: San Francisco Bay Area

Our customer is seeking a Laboratory Systems Validation Engineer who is well versed in laboratory Instrument or CSV processes within a pharmaceutical environment, and who has laboratory related CSV experience. Experience with LabX highly preferred.

Must have hands experience on Lab Systems Validation or Lab Instrument Qualification. You will be primarily responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.

Job Description:
  • Responsible for planning, scheduling, and executing validation efforts for LabX system.
  • Ensures validation is being performed per established procedure, review validation documentation, and coordinating between direct groups for the same
  • Identify intended use of laboratory instrument, develop qualification deliverables per current company procedure and standards, and coordinate validation activities between vendor, cross functional teams and users.
  • Communicate to different stakeholders and management on the progress of validation efforts
  • Work with project team for identifying the activities of project, 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.

Application Instructions

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