Biotechnology Validation Specialist

7 days ago

Sydney, New South Wales, Australia beBeeValidation Full time $100,000 - $140,000
Commissioning Qualification Validation Engineer

This role requires a high level of expertise in Commissioning, Qualification, and Validation (CQV) to ensure compliance with regulatory requirements. The ideal candidate will have experience in validating GxP facilities, equipment, and utilities, as well as drafting and executing validation documentation.

  • Key responsibilities include commissioning, qualifying, and validating facilities, equipment, and utilities; writing and executing protocols for validation activities; and conducting risk analyses, design reviews, and executing FAT/SAT, IQ, OQ, and PQ tasks.
  • The successful candidate will also be responsible for preventative maintenance, process improvements, and establishing validation standards.

Required Skills:

  • Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
  • 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
  • Sound industry knowledge, project proficiency, and autonomy expected.
  • Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
  • Understands current risk-based validation approaches.
  • Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
  • Experience with system impact assessment and risk assessment.
  • Good knowledge of the code of GMP and PIC/S code.
  • Previous experience in the Life Sciences Industry is required.
  • Previous experience in GxP Industries are required.
  • Must be adaptable, customer service oriented, have a positive attitude.
  • Excellent organizational skills.
  • High attention to detail.
  • Must have strong written and verbal communication skills.

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