Software Validation Expert

5 days ago

Brisbane, Queensland, Australia beBeeComputer Full time $120,000 - $150,000
Computer Systems Validation Specialist

We are seeking a highly skilled Computer Systems Validation Specialist to join our team. The successful candidate will be responsible for developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.

This specialist will develop GxP computer validation and 21 CFR Part 11 related documentation, such as assessments, plans, URS, FRS, RTM, and summary reports. Other duties may include:

  • Preparing/reviewing validation documentation related to projects/change controls
  • Managing change controls and other compliance-related tasks, e.g., non-conformances
  • Participating in the review of current and future CSV procedures and policies
  • Analyzing the results of testing and determining the acceptability of results against predetermined criteria
  • Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
  • Identifying current and anticipated requirements for compliant computerized operations and suggesting methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation
  • Coordinating with other departments or outside contractors/vendors to complete validation tasks
  • Participating in regulatory audits and communicating company's computer validation policies
  • Assessing company's computer systems and identifying any potential Part 11 or Annex 11 gaps
  • Managing projects and preparing status reports using Microsoft Project and other communication tools
  • May supervise, lead, or manage lower-level personnel
Requirements

The ideal candidate will possess a Bachelor's degree in a Computer Science or Engineering field or equivalent experience. A minimum of 2-7 years' experience with Computer Systems Validation is required, along with a minimum of 2-7 years' experience working in a GMP environment.

Experience in Data Integrity with GAMP and 483 compliance, deep 21 CFR Part 11 experience is highly desired. Experience in biotech and pharma is preferred over medical device. Experience with MES, Delta V, PI is a plus.

The selected candidate will have an opportunity to work with recognized subject matter experts, bringing lifesaving therapies to market, including COVID-19 vaccines and therapies.

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