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Job ID :
50441BR
Location :
Australia - Adelaide
:
Job Description

Key Responsibilities:

  • Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support certification standards
  • Preparation and execution of validation protocols (equipment, cleaning, computerised systems and processes)
  • Assisting system owners with impact assessments and identifying qualification/validation requirements.
  • Supervising all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules
  • Supervising technicians, fitters and contractors as required when external support is utilised for qualification activities
  • Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts
  • Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
  • Creating/maintaining qualification related records, procedures, documents and drawings
  • Ensuring compliance with health and safety (EHS) legislation
  • Engaging with project teams to help with selection, installation and commissioning of new equipment
  • Any other task required from time to time to assist the efficient running of the Company’s business.

The successful candidate for this Validation Specialist position will have:

  • Validation experience within a GMP environment
  • Demonstrable validation experience in a medical device ISO13485, biopharmaceutical, consumer healthcare or related industry.
  • Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA
  • Knowledge of commissioning and equipment validation to include autoclaves, temperature controlled storage and automated production lines, cleaning validation experience
  • Proven problem solving skills/diagnosing faults/resolving qualification issues
  • Excellent planning and time management ability
  • The ability to adapt to rapid changes in project priorities and meeting aggressive timelines
  • The ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.


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