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Senior Pharmaceutical Commissioning Qualification Validation Engineer
2 months ago
CAI is a 100% employee-owned company established in 1996, with a global presence of nearly 700 people. We specialize in providing commissioning, qualification, validation, start-up, project management, and consulting services to FDA-regulated and other mission-critical industries.
We put our clients' interests first and strive to deliver exceptional results. Our approach is built on a set of Foundational Principles that guide our actions:
- We act with integrity
- We serve each other
- We serve society
- We work for our future
As employee-owned company, we prioritize teamwork and collaboration. We invest in our employees' growth and development, providing hands-on certifications and professional training. Our culture is built on respect, a can-do attitude, and a commitment to excellence.
Job DescriptionWe are seeking a Senior CQV Engineer to join our team in Australia. The successful candidate will be responsible for developing documentation to support Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
The role involves:
- Developing documentation for 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
- Planning and coordinating work, and directing small teams in document development and/or execution
The ideal candidate will have:
- 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
- Experience in facilities and equipment startup, walk-downs & 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
The successful candidate will be able to:
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients
- Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ Executions and System Walkdowns
- Experience in planning/directing C&Q activities
- Familiarity with Baseline Guide 5 (Second Edition)
We offer a highly competitive salary, continuing education opportunities, and the chance to work on cutting-edge projects in a rapidly evolving field. We are an equal opportunity employer and proud to employ veterans and promote diversity and inclusion in our workplace. #LI-JW1
