Qualification Engineer

7 days ago

Sydney, New South Wales, Australia beBeeValidation Full time $120,000 - $150,000
Commissioning Qualification Validation Specialist Role

The Commissioning Qualification Validation Specialist will be responsible for ensuring the smooth operation of facilities, equipment, and utilities in assigned projects. This involves writing and executing validation protocols, conducting risk assessments, and performing preventative maintenance to guarantee compliance with regulatory requirements and quality standards.

Key Responsibilities:
  • Validate GxP facilities, equipment, and utilities to ensure operational integrity
  • Draft, execute, review, and approve validation documentation to ensure adherence to cGMP requirements, regulatory needs, and quality benchmarks
  • Coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ activities
  • Perform regular maintenance and assess potential risks
Required Skills and Qualifications:
  • 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 environments
  • Strong industry knowledge, project proficiency, and autonomy expected
Benefits:

This role offers the opportunity to work on diverse projects, develop your expertise, and contribute to the success of our organization.

Additional Information:

Please note that this is a general job description and may be subject to change based on business needs.

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