Senior Pharmaceutical Commissioning Qualification Validation Engineer
CAIBrisbane, Australia
On-site Full-time
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Experience Level
Senior
Qualifications
BS in Engineering or a related field (advanced degrees preferred). Proven experience in CQV processes within the pharmaceutical or biotechnology sectors. Strong communication skills and the ability to work collaboratively in a team environment.
CAI is on the lookout for talented professionals with diverse experience in the fields of commissioning, qualification, and validation to become a part of our dynamic team in Australia. A background in the pharmaceutical, medical device, or biotechnology sectors is essential.
About CAI:
Founded in 1996, CAI is a 100% employee-owned enterprise that has expanded year after year, reaching nearly 700 employees globally. We specialize in commissioning, qualification, validation, start-up, project management, and consulting services aimed at ensuring operational readiness for FDA-regulated and other mission-critical industries.
Are You Ready?
Our philosophy is straightforward: we prioritize our clients' needs, persist until we achieve the desired outcome, and are committed to doing whatever it takes to succeed.
As CAI employee-owners, we pledge to uphold our Foundational Principles both professionally and personally:
We act with integrity
We support one another
We contribute to society
We work towards a sustainable future.
At CAI, individual success translates into collective achievement; we strive to reach team objectives diligently. We emphasize Team Before Self, demonstrate Respect for Others, and foster a can-do attitude, which has been pivotal to our remarkable growth.
As a CAI agent, you will have access to cutting-edge technologies in advanced medicine. You will collaborate with recognized subject matter experts, positioning YOU as a crucial contributor in the development of life-saving therapies, including COVID-19 vaccines and treatments. We are committed to investing in YOUR future through hands-on certifications and professional training. Our collaborative culture guarantees that our clients benefit from exceptional work across our comprehensive range of professional services.
Key Responsibilities:
Position Overview:
We invite applications for the position of Senior CQV Engineer to enhance our growing operations in Australia. The CQV Engineer is tasked with creating documentation to facilitate Commissioning, Qualification, and Validation processes. Key responsibilities include writing and executing protocols, conducting field verifications, and compiling summary reports at client sites.
The Senior CQV Engineer at CAI will:
Develop comprehensive documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. This role also entails protocol writing and execution (including field verification), as well as the development of summary reports at client locations. Additional duties include planning and coordinating work and leading small teams in document development and execution.
Qualifications:
BS in Engineering or a related field (advanced degrees preferred). Proven experience in CQV processes within the pharmaceutical or biotechnology sectors. Strong communication skills and the ability to work collaboratively in a team environment.
About CAI
CAI is a leading employee-owned company specializing in operational readiness for FDA-regulated and mission-critical industries, offering innovative solutions in commissioning, qualification, validation, and project management since 1996.
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