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Senior Validation Specialist

4 weeks ago


Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

Job Summary

Thermo Fisher Scientific Inc. is seeking a highly skilled Senior Validation Engineer to join our Equipment, Utilities, and Facilities Validation department. As a key member of our team, you will play a vital role in maintaining a lifecycle approach to validation, ensuring compliance with regulatory guidelines and international quality requirements.

Key Responsibilities

  • Assist in the commissioning and qualification of equipment, facilities, and utilities, ensuring compliance with pertinent regulations.
  • Prepare, execute, and review validation documentation, including FDS, DQ, IOQ, PQ, CSV, and track anomalies during qualification activities.
  • Develop project plans for validation processes and provide validation support and 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 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.

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.