Principal Validation Specialist

2 days ago

Melbourne, Victoria, Australia beBeeMicrobiologist Full time $80,000 - $120,000

Validation Associate Position Summary

This role focuses on the validation of instrumentation and software in a laboratory setting.

The successful candidate will be responsible for drafting User Requirement Specifications (URS), executing validation test protocols, and preparing Validation Summary Reports. Additionally, they will assist with the development and review of procedures required for usage, calibration, verification, and maintenance of new laboratory instrumentation.

  • A Bachelor's or Master's degree in Microbiology or a related field is required.
  • Proven experience in a pharmaceutical/microbiology environment is necessary.
  • Strong knowledge of cGMP/GLP regulations and regulatory requirements is essential.
  • Experience with environmental monitoring test requirements and microbial identification testing is beneficial.
  • Excellent verbal and written communication skills are required, as well as strong technical problem-solving and analytical skills.

Key Responsibilities:

  • Drafting of URS for new instrumentation and/or software.
  • Execution of validation test protocols (IQ,OQ and PQ) for new instrumentation and/or software.
  • Preparation of Validation Summary Reports on completion of validation activities for new instrumentation and/or software.
  • Assistance with the development and review of procedures required for usage, calibration, verification, and maintenance of new laboratory instrumentation.

Benefits of the Role:

  • Opportunity to work in a dynamic and inclusive environment that values diversity and promotes equality.
  • Chance to develop and apply technical skills in a real-world setting.
  • Collaborative team atmosphere with experienced professionals.

Additional Information:

  • We strive to create a safe and supportive workplace culture.
  • Our organization prioritizes employee growth and development.

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