Senior Pharmaceutical Commissioning Qualification Validation Specialist
6 days ago
CAI is a 100% employee-owned company with a strong presence in Australia, providing commissioning, qualification, and validation services to the pharmaceutical, medical device, and biotechnology industries.
We pride ourselves on our commitment to excellence, integrity, and customer satisfaction. Our team of experts is dedicated to delivering high-quality services that meet the stringent requirements of the FDA and other regulatory bodies.
Job SummaryWe are seeking a highly skilled Senior CQV Engineer to join our team in Australia. The successful candidate will be responsible for developing documentation to support commissioning, qualification, and validation activities, as well as planning and coordinating work, and directing small teams in document development and execution.
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.
- Plan and coordinate work, and direct small teams in document development and execution.
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
- 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.
- 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.
CAI offers a highly competitive salary, continuing education opportunities, and the chance to work on cutting-edge projects in a highly evolving field. We are an equal opportunity employer and are proud to employ veterans and promote diversity and inclusion in our workplace.
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