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Senior Validation Engineer

2 months 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. 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 in the commissioning and qualification of Equipment, Facilities, and Utilities, ensuring compliance with pertinent regulations (e.g., TGA, FDA, EMA).
  • Coordinate tracking of validation protocol execution status and ensure completion of validation projects per required schedules.
  • 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 Brisbane site.
  • Responsible for continuous improvement in costs and results within validation activities and EH&S in 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.

Skills and Abilities:

  • Strong communication and interpersonal skills.
  • Good presentation, planning, and organizational skills.
  • Confirmed leadership and mentorship abilities.
  • IT foresight and adaptability.
  • Ability to collaborate with complementary teams.
  • Demonstrated dedication to continuous improvement and customer focus.
  • Ability to balance multiple projects and tasks simultaneously while meeting agreed due dates.
  • Strong attention to detail and dedication to quality orientation principles.

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