Description

You will own the validation lifecycle for computer systems within a controlled cGxP environment.

Responsibilities

• Author and review computer system validation lifecycle documents.
• Execute validation lifecycle deliverables using an SDLC tool (KNEAT).
• Write change controls and deviations/CAPAs following GxP workflows.
• Manage System Administration activities and Document Management within a QMS framework.
• Support data integration and system connectivity for laboratory instrumentation.

Required Skills

• 4+ years experience in a controlled cGxP environment.
• Bachelor's degree in STEM or a relevant discipline.
• Experience authoring and reviewing validation lifecycle documentation.
• Familiarity with Computer Systems Validation standards and deliverables.
• Experience with Document Management and QMS systems.
• Experience with ServiceNow and System Administration.
• Experience working in regulated environments.
• Skills in System Admin, Data Integration, and QA.

Preferred Skills

• Experience with Enterprise Instrumentation Systems (e.g., Chromeleon).
• Experience in life sciences, pharma/biotech, or high-tech industries.

Key Skills

Education

Bachelor's degree