Pharmaceutical Systems Documentation Specialist

1 week ago


Melbourne, Victoria, Australia beBeeQualification Full time $120,000 - $160,000
Job Overview:

We are seeking a highly skilled Commissioning, Qualification and Validation (CQV) Engineer to join our team.

The successful candidate will be responsible for developing documentation to support CQV activities, including protocol writing and execution, field verification and development of summary reports at client sites.

Key Responsibilities:
  • Support documentation for the Commissioning, Qualification and Validation of pharmaceutical facilities, utilities and equipment.
  • Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
  • Provide cGMP leadership and guidance for the integration and delivery of CQV services for our clients in the life sciences sector.
Requirements:
  • Bachelor's or Master's degree in a relevant science or engineering field, or equivalent years of hands-on experience.
  • 2-7 years' experience performing commissioning and/or qualification activities in an FDA-regulated industry.
  • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
  • High attention to detail.
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
What We Offer:
  • A highly competitive salary.
  • Continuing education opportunities.
  • Challenging projects in a rapidly evolving field.


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