High-Quality Biotech Validation Specialist

2 days ago

Brisbane, Queensland, Australia beBeeValidation Full time $120,000 - $145,000
Biotechnology Validation Engineer

The primary goal of this position is to guarantee the high-quality results in projects related to the biotechnology landscape. To achieve this, a Commissioning, Qualification, and Validation (CQV) Engineer will be responsible for working on assigned projects, collaborating with a talented team.

This includes commissioning, qualifying, and validating GxP facilities, equipment, and utilities, as well as drafting, executing, reviewing, and approving validation documentation to ensure compliance with cGMP requirements, regulatory requirements, and quality standards.

Additionally, the successful candidate will develop and execute validation protocols, including IQ/OQ/PQ test scripts, validation project plans, and requirement specifications. They will also initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ activities.

Other responsibilities include conducting preventative maintenance, performing risk assessments to identify areas for improvement, recommending process improvements, establishing validation standards, developing performance testing, and quality control measures.

Requirements

  • A bachelor's degree in a relevant science or engineering field, or equivalent years of hands-on experience.
  • At least 3 years' experience in the biotechnology and pharmaceutical industries, with a minimum of 2 years' relevant experience performing CQV activities within a 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.
  • Understands current risk-based validation approaches.
  • Excellent written and verbal communication skills.
  • Strong organizational skills and attention to detail.

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