Job Description

• Support CSV lifecycle activities for manufacturing, automation, and laboratory systems.
  
• Develop and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Traceability Matrices.
  
• Review system changes and support change control activities in line with site procedures.
  
• Work closely with Automation, IT, Engineering, and Quality teams to ensure compliant system delivery.
  
• Support periodic reviews, audit readiness activities, and regulatory inspections.
  
• Assist with deviation investigations, CAPAs, and root cause analysis activities related to validated systems.
  
• Ensure validation activities are completed in accordance with GMP, GAMP 5, 21 CFR Part 11, and Data Integrity requirements.
  
• Support system implementations, upgrades, and remediation projects across the site.

• 5+ years’ experience in Computer Systems Validation within Pharmaceutical or regulated manufacturing environments.
  
• Strong knowledge of CSV lifecycle activities and validation documentation development/execution.
  
• Experience validating automation systems, manufacturing systems, or infrastructure platforms.
  
• Good understanding of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
  
• Experience supporting audits, inspections, deviations, and CAPA activities.
  
• Familiarity with change management and quality management systems within regulated environments.
  
• Strong documentation, communication, and stakeholder management skills.
  
• Ability to work across multidisciplinary project and operational teams in a fast-paced GMP environment.