Solution Architect – Validation & Testing

Role Overview

• Handle various computer system validation activities for different cross functional programs across West Pharma.
• Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
• Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
• Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
• Participate in internal audits and regulatory inspections, providing validation rationale and documentation support.

Requirements

• Requires bachelor’s degree in computer science or Information Technology
• Minimum 3 years of relevant experience (preferably in Medical Device or Pharma validation of Software)
• Prior working knowledge on tools like SAP, QMS, LIMS
• Good understanding of GxP computerized system lifecycle principles (GAMP 5)
• Ability to guide cross-functional teams in integrating validation requirements during system implementation
• Prior knowledge on documentation review skills with attention to compliance, traceability, and audit readiness.

Benefits

• health insurance
• paid time off
• professional development programs