Biotechnology Validation Specialist

4 days ago

Sydney, New South Wales, Australia beBeeValidation Full time $90,000 - $120,000
Job Overview

We are seeking a highly skilled Biotechnology Validation Specialist to join our team in an exciting and dynamic biotechnology landscape.

Key Responsibilities:

  • Lead the commissioning, qualification, and validation of GxP facilities, equipment, and utilities in assigned projects.
  • Develop and execute validation protocols, ensuring compliance with cGMP requirements, regulatory standards, and quality control measures.
  • Draft and execute validation documentation, including project plans, requirement specifications, IQ/OQ test scripts, and validation summary reports.
  • Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ activities.
  • Conduct preventative maintenance and perform risk assessments to ensure optimal system performance.
  • Collaborate with cross-functional teams to identify process improvements and implement best practices.
  • Develop and maintain validation standards and quality control measures to ensure ongoing compliance.
  • Perform equipment and clean room validation to ensure accurate results.

Requirements:

  • 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.
  • Solid industry knowledge, project proficiency, and autonomy expected.
  • Experienced in CQV of facility/utility/equipment, including PW, HVAC, and process or laboratory equipment.
  • Familiarity with current risk-based validation approaches.
  • Ability to author, revise, review, and complete controlled documents for validation projects.
  • Experience with system impact assessment and risk assessment.
  • Good understanding of GMP and PIC/S code principles.
  • Previous experience in the Life Sciences Industry required.
  • Adaptable, customer service oriented, positive attitude, excellent organizational skills, high attention to detail, strong written and verbal communication skills required.

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