Computer Systems Validator

2 days ago

Brisbane, Queensland, Australia beBeeComputerSystemsValidation Full time $87,881 - $121,491
Job Description

We are seeking a skilled professional to join our team as a Computer Systems Validation (CSV) Engineer. The successful candidate will be responsible for developing protocols, test scripts, identifying gaps, and directing resolution plans.

The CSV Engineer will also be responsible for writing GxP computer validation documentation and 21 CFR Part 11 related documents. Additional duties may include:

  • Preparing/reviewing validation documentation related to projects/change controls.
  • Managing change controls and compliance-related tasks.
  • Participating in reviewing current and future CSV procedures and policies.
  • Analysing testing results and determining acceptability against predetermined criteria.
  • Investigating and troubleshooting problems and suggesting solutions or recommendations.
  • Identifying current and anticipated requirements for compliant computerized operations and suggesting methods for implementation and maintenance.
  • Coordinating with other departments or outside contractors/vendors to complete validation tasks.
  • Participating in regulatory audits and communicating company policies.
  • Assessing company computer systems and identifying potential Part 11 or Annex 11 gaps.
  • Managing projects and preparing status reports using Microsoft Project and other communication tools.
  • Supervising, leading or managing lower-level personnel.
Required Skills and Qualifications
  • 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.
  • Experience in biotech and pharma is preferred over medical device.
  • Experience with MES, Delta V, PI is a plus.
Benefits

As an employee-owned company, we offer a collaborative culture that ensures customers benefit from high-quality work across all services.

Our employees enjoy certifications and training opportunities, along with the chance to grow and develop their skills.

Others
  • Excellent oral and written communication skills in English/Fluent in English.
  • Able to travel domestically and internationally as required.
  • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
  • High attention to detail.
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
  • Independent individual and yet a strong team player.

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