CSV Specialist

2 days ago

Brisbane, Queensland, Australia beBeeEngineering Full time $90,000 - $130,000

We are currently seeking a Computer Systems Validation (CSV) Engineer to join our team in Australia.

The ideal candidate will have experience in developing and executing protocols, test scripts, and validation documentation. They will also be responsible for managing change controls, coordinating with other departments, and participating in regulatory audits.

Responsibilities:
  • Develop and execute protocols and test scripts
  • Manage change controls and compliance related tasks
  • Coordinate with other departments or outside contractors/vendors
  • Participate in regulatory audits and communicate company's computer validation policies
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 21CFR Part 11 experience highly desired
Benefits:
  • Highly Competitive Salary
  • Continuing education (internal and external)
  • Opportunities to work on cutting edge projects in a highly evolving field

As an equal opportunity employer, we pledge that CAI will be operated in a way that is fair and equitable to all.

This job description is not all inclusive and you may be asked to do other duties.

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