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Computer Systems Validation Specialist

2 months ago

Melbourne, Victoria, Australia Cagents Full time
Computer Systems Validation Engineer

We are seeking a highly skilled Computer Systems Validation Engineer to join our team in Australia. As a key member of our team, you will be responsible for developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.

Key Responsibilities:

  • Develop and execute protocols and test scripts to ensure compliance with GxP regulations
  • Identify gaps in current systems and develop plans for resolution
  • Consult with cross-functional teams to ensure compliance with regulatory requirements
  • Analyze results of testing and determine acceptability against predetermined criteria
  • Investigate and troubleshoot problems, determining solutions or recommendations for changes and/or improvements
  • Coordinate with other departments or outside contractors/vendors to complete validation tasks
  • Participate in regulatory audits and communicate company's computer validation policies
  • Assess company's computer systems and identify any potential Part 11 or Annex 11 gaps

Requirements:

  • BS in a Computer Science or Engineering field or equivalent experience
  • Minimum 2-7 years' experience with Computer systems validation
  • Minimum 2-7 years' experience working in a GMP environment
  • Experience in Data Integrity with GAMP and 483, compliance, deep 21 CFR Part 11 experience highly desired
  • Experience in biotech and pharma is preferred over medical device
  • Experience with MES, Delta V, PI is a plus

What We Offer:

  • Highly competitive salary
  • Continuing education (internal and external)
  • Opportunities to work on cutting-edge projects in a highly evolving field