Pharmaceutical Commissioning Expert with Senior Leadership

9 hours ago


Brisbane, Queensland, Australia CAI Full time

CAI is seeking a skilled pharmaceutical commissioning expert to join our team in Australia. With a strong background in commissioning, qualification, and validation (CQV), you will be responsible for developing documentation to support the CQV process. This includes protocol writing and execution, field verification, and development of summary reports at client sites.

About CAI

We are a 100% employee-owned company established in 1996, with a global presence of nearly 700 people. Our team provides commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness to FDA-regulated industries.

Job Description

We are looking for a Senior CQV Engineer to join our growing operations in Australia. The successful candidate will have experience in facilities and equipment startup, walk-downs & troubleshooting, utilities (WFI, RO, HVAC), building automation, or other pharmaceutical manufacturing processes and equipment.

Key Responsibilities:
  • Develop 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 Life Sciences clients.
Requirements:
  • BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.
  • 5 – 12 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.
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
Estimated Salary: AU$120,000 - AU$150,000 per year

We offer a highly competitive salary, continuing education opportunities, and a chance to work on cutting-edge projects in a highly evolving field. If you're a motivated and experienced professional looking to take your career to the next level, we encourage you to apply.



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