About Us:

Celebrating over 30 years, CMAX is one of Australia’s largest, longest running and most experienced clinical trial units conducting successful world-leading research for local and international clients, specialising in a range of early-phase trials.

These studies have resulted in the advancement of global medicines and technologies, from cancer treatment and pain control to early warning bio-devices and hormone replacement therapies.

CMAX operates a 78-bed capacity state-of-the-art facility, primely positioned opposite the Royal Adelaide Hospital and SAHMRI building in the West end of the city. 

In 2025, we were proud to announce that CMAX was acquired by New Zealand Clinical Research (NZCR), to become Australasia’s largest independent multi-phase clinical research organisation. Our CMAX Adelaide based workforce is over 400+ staff and is still growing, we are now strengthened even further by our ability to leverage knowledge and experience from our NZCR counterparts.

About the role:

The Validation Specialist is responsible for maintaining the Computer System Validation (CSV) framework, policies and all associated template documents. The CSV will plan, execute, document, and maintain CSV activities to ensure all digital systems systems comply with regulatory requirements and CMAX SOPs and policies.

 The key responsibilities of the Validation Specialist include leading validation efforts across all digital platforms, identifying gaps or process improvements in validation procedures, and producing documentation to support validation efforts. The role also requires an extremely high-level attention to detail, in conjunction with a sound understanding of validation models and how to apply them to various digital systems.

The Validation Specialist will achieve effective outcomes as follows:

•  Lead validation activities (IQ/OQ/PQ) across digital systems;

• Ensure compliance with ICH GCP, FDA 21 CFR Part 11, EMA, GAMP 5;

• Work closely with IT, QA, and business teams to meet user and regulatory needs;

• Outline validation approaches and explain associated documentation in audits by external parties;

• Author and review validation plans, risk assessments, and traceability matrices;

• Participate in vendor qualifications, both in-person and virtual;

• Contribute to data integrity programs;

• Train staff and promote a quality focused culture.

About you:

• Formal qualifications in CSV (Required);

• 5+ years’ experience in CSV in pharma, biotech, medical devices or other highly regulated industry;

• Certification in ICH GCP (Desirable);

• Qualifications in GAMP 5 (Desirable);

• Qualifications in data integrity principles (Desirable);

• Strong knowledge of ICH GCP, and FDA regulations;

• Experience validating cloud-based solutions;

• Detail oriented, analytical, and proactive team player;

• A clear communicator, with the ability to explain complex concepts to a wide variety of audiences

 If you are looking for a challenging and exciting opportunity, then please apply by:

• Attaching a CV which outlines your experience with a focus on the above criteria;

• Include a cover letter, outlining why you believe this role is for you.

Applications will close on Sunday 12 July 2026.

Only candidates with approved rights to work full time in Australia will be shortlisted for this role.

Please note that we may be conducting interviews during the advertisement period and retain the right to withdraw the advert should we select a successful applicant prior to the closing date.