CSV Engineer

The successful candidate will typically be responsible for the following activities (not limited to):

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• Collaborate with engineering teams and external equipment suppliers to ensure deliverables meet required qualification and compliance standards.
  
• Ensure computerised system validation activities are performed in accordance with applicable procedures and regulatory expectations.
  
• Develop and manage formal change management records for system updates, improvements, or modifications.
  
• Prepare and execute documentation such as user requirement specifications, validation plans, testing protocols, and summary reports for the introduction or modification of regulated systems.
  
• Establish system specifications and operational procedures aligned with recognised industry standards.
  
• Prepare or update risk assessments supporting system operation and compliance requirements.
  
• Maintain traceability documentation linking system requirements through validation and testing activities.
  
• Develop documentation describing system data lifecycle processes where required.
  
• Participate in equipment testing activities at supplier facilities where applicable.
  
• Work collaboratively with project teams to ensure key deliverables and milestones are achieved within planned timelines.
  
• Ensure all work activities comply with applicable procedures, guidelines, and regulatory expectations relevant to controlled operational environments.
  

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• Degree or equivalent qualification in engineering, computer systems, life sciences, or a related technical discipline, or equivalent industry experience.
  
• Several years of experience working with validation or qualification of regulated computerised systems within a controlled operational environment.
  
• Demonstrated experience supporting the full lifecycle of system validation activities.
  
• Familiarity with regulatory expectations relating to computerised systems, data integrity, and documentation practices.
  
• Experience producing validation documentation packages for the implementation or modification of regulated systems.
  
• Strong written and verbal communication skills. xcfaprz
  
• Strong analytical and problem-solving capabilities.