Expert Validator

2 days ago


Melbourne, Victoria, Australia beBeeValidation Full time $122,300 - $181,009
Senior Validation Specialist

We are seeking a Senior Validation Specialist to lead our supply chain optimization project. This role will play a pivotal part in ensuring the quality and reliability of our equipment and packaging systems.

The successful candidate will be responsible for developing, executing and managing validation protocols, plans and reports. They will also partner with engineering, packaging, quality assurance and project teams to define requirements and timelines.

To be successful in this role, you will need to have a strong understanding of validation lifecycle principles and regulatory expectations. You will also need to be able to communicate clearly with stakeholders and collaborate cross-functionally.

Key Responsibilities:

  • Lead validation efforts for equipment and packaging systems (IQ/OQ/PQ)
  • Develop, execute and manage validation protocols, plans and reports
  • Partner with Engineering, Packaging, Quality Assurance & Project teams to define requirements & timelines
  • Ensure compliance with regulatory and internal quality standards (TGA, PIC/s, cGMP)
  • Identify risks and recommend solutions to improve validation processes and outcomes
  • Provide technical input during project meetings, audits and inspections
Requirements:
  • Tertiary qualification in Engineering, Science, or related technical field
  • 5+ years' experience in validation within a manufacturing and packaging environment
  • GMP experience is essential
  • Proven expertise in commissioning, qualification and validation of packaging equipment
  • Excellent documentation, risk assessment and root cause analysis skills
  • Strong understanding of validation lifecycle principles and regulatory expectations
  • Ability to collaborate cross-functionally and communicate clearly with stakeholders


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