Computer System Validation Engineer

Carl Zeiss Pty Ltd

Lisboa, Portugal
Validation planning and execution
Risk assessment and mitigation
Iq, oq, pq execution
Responsible for ensuring that all computer systems and applications used within the organization comply with regulatory requirements and industry standards

Job Summary

  • Responsible for ensuring that all computer systems and applications used within the organization comply with regulatory requirements and industry standards.
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing systems.
  • Work closely with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.

Matching Summary

Responsible for ensuring that all computer systems and applications used within the organization comply with regulatory requirements and industry standards.

Skills & Requirements

Must-have

  • Validation Planning and Execution
  • Risk Assessment and Mitigation
  • IQ, OQ, PQ Execution
  • Regulatory Compliance (GxP, FDA 21 CFR Part 11)
  • Medical Device Standards Expertise

Nice-to-have

  • Cross-functional team collaboration
  • Continuous Improvement initiatives
  • German language proficiency

Key Requirements

  • Minimum 5 years experience in regulated industry
  • Experience with ERP, QMS, LIMS, MES validation
  • Degree in Engineering or Software
  • Fluent in English

Work Rights

Not specified

Tailored Resume

Cover Letter