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Computer System Validation (CSV) Specialist

CAISydney
On-site Full-time

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Experience Level

Experience

Qualifications

Qualifications:• Minimum 3 years’ experience in Computer System Validation (CSV) within GxP environments.• In-depth knowledge of GAMP 5 guidelines and data integrity principles.• Familiarity with relevant regulatory frameworks and compliance requirements.

About the job

CAI is actively seeking talented professionals with diverse experience in the realms of commissioning, qualification, and validation to enhance our dynamic team in Australia. Proven experience 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 exponentially, now boasting more than 800 dedicated employees globally. We specialize in offering commissioning, qualification, validation, start-up, project management, and consulting services tailored to operational readiness for FDA-regulated and other critical industries.
 
Are You Ready?
 
Our guiding principle is straightforward; we prioritize our clients’ interests, pursue excellence relentlessly, and are committed to achieving the best outcomes.
 
As proud owners of CAI, we uphold our Foundational Principles in both our professional and personal lives:
• Integrity in all actions
• Support for one another
• Commitment to societal service
• Focus on a sustainable future
 
With employee ownership, each person’s success contributes to the collective achievement; we strive diligently to meet our team objectives. Our ethos revolves around placing Team Before Self, demonstrating Respect for Others, and maintaining a proactive mindset, key factors in our remarkable growth.
 
As a CAI agent (employee), you will engage with pioneering technologies in the advanced medicine sector. You will collaborate with leading subject matter experts, enabling you to play a pivotal role in the development of life-saving therapies, including COVID-19 vaccines and treatments. Our culture is centered on investing in YOUR future through hands-on certifications and professional training, fostering an environment where our clients receive exceptional service across our comprehensive range of professional offerings.
 
About the Role
We are in search of a skilled and proactive Computer System Validation (CSV) Specialist to join a state-of-the-art advanced therapeutics facility located in Australia’s largest health, education, research, and innovation precinct.

This full-time position is ideal for individuals with a robust background in CSV within GxP environments, eager to make a significant impact in a rapidly evolving, high-integrity environment.

Work Location: Sydney, Australia
Employment Type: Full Time Employee

Requirements include:
• A minimum of 3 years’ experience in CSV within the pharmaceutical, biotech, or medical device fields.
• Comprehensive understanding of GAMP 5, data integrity, and applicable regulatory frameworks.

About CAI

CAI is a pioneering company with a commitment to employee ownership and excellence in operational readiness services. As a forward-thinking organization, CAI has established itself as a leader in the industry, dedicated to enhancing the delivery of critical therapies and technologies.

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