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Pharmaceutical Commissioning Qualification Validation Specialist

2 months ago


Melbourne, Victoria, Australia CAI Full time
Job Description

CAI is seeking a highly skilled Commissioning and Qualification Engineer to join our team in Australia.

About CAI

CAI is a 100% employee-owned company established in 1996, with a strong commitment to excellence and customer satisfaction. We provide a wide range of services related to operational readiness, including commissioning, qualification, validation, start-up, project management, and consulting.

Our Approach

We put the client's interests first and strive to deliver exceptional results. Our team is dedicated to living our Foundational Principles, which include acting with integrity, serving each other, serving society, and working for our future.

Job Responsibilities

  • Develop documentation to support commissioning, qualification, and validation activities
  • Write and execute protocols, conduct field verification, and develop summary reports at client sites
  • Support the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment
  • Provide leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients

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
  • Experience in facilities and equipment startup, walk-downs, and troubleshooting, utilities (WFI, RO, HVAC), building automation, or other pharmaceutical manufacturing processes and equipment
  • 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
  • Ability to work independently, while quickly building and nurturing a project team

What We Offer

  • Highly competitive salary
  • Continuing education (internal and external)
  • Opportunities to work on cutting-edge projects in a highly evolving field

Equal Opportunity Employer

CAI is an equal opportunity employer and is proud to employ veterans and promote diversity and inclusion in our workplace. We pledge to operate in a way that is fair and equitable to all – our employees, our customers, and the broader society.