Senior Validation Engineer

3 days ago


Brisbane, Queensland, Australia Thermo Fisher Scientific Full time
Senior Validation Engineer

Thermo Fisher Scientific Inc. is seeking a highly skilled Senior Validation Engineer to join our team in Brisbane. As a key member of our Equipment, Utilities, and Facilities Validation department, you will play a critical role in maintaining a lifecycle approach in line with regulatory guidelines, the Site Validation Master Plan, project-specific Validation Plans, and departmental SOPs.

Key Responsibilities:

  • Assist the Validation Department in commissioning and qualifying equipment, facilities, and utilities, ensuring compliance with pertinent regulations (e.g., TGA, FDA, EMA).
  • Prepare, execute, and/or review validation documentation, including FDS, DQ, IOQ, PQ, CSV, and track and resolve anomalies during qualification activities.
  • Develop project plans for validation processes and provide validation support and associated mentorship for equipment, facility, and utilities qualification processes.
  • Represent validation at external and internal audits and be responsible for performing validation activities and achieving assigned targets, standards, and/or departmental goals.
  • Supervise external technological, legal, and regulatory developments around validation and assess their applicability to and consequences for the Brisbane site.
  • Responsible for continuous improvement in costs and results within validation activities and EH&S in assigned validation activities.

Requirements:

  • Bachelor's degree in Science, Engineering, or Statistics, or meaningful work experience.
  • Preferably 5 years of confirmed Biotech experience in commercial-scale manufacturing operations.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


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