Data Validation Engineer

2 days ago

Brisbane, Queensland, Australia beBeeComputer Full time $120,000 - $140,000
About Us

We are a global company with over 800 employees, established in 1996.

Our approach is built around our Foundational Principles: integrity, serving each other and society, and working for our future.

Requirements:

We are seeking experienced professionals to develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution.

  • Writes GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
  • Manages change controls and other compliance-related tasks e.g., non-conformances.
  • Participates in the review of current and future CSV procedures and policies.
  • Analyses the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Participates in regulatory audits and communicates company's computer validation policies.
  • Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.
  • Manages projects and prepares status reports using Microsoft project and other communication tools.
Key Qualifications:

A degree in 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.

Experience in biotech and pharma is preferred over medical device.

Experience with MES, Delta V, PI is a plus.

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