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Job ID :
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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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