Validation Specialist

Who We Are

Cell Therapies Pty Ltd (CTPL) is a commercial Contract Development and Manufacturing Organisation (CDMO) located within the Peter MacCallum Cancer Centre. We specialise in the development and delivery of cell and gene therapies and have more than 20 years’ experience in this area.

The growth of CTPL will continue through our commitment to supporting both Australian and international research and development activities, alongside delivery of commercial contracts to provide these highly personalised therapies to patients in Australia and the region.

About the Role

We are seeking a motivated Validation Specialist who will report to the Validation Manager to complete validation activities to support our facility and product manufacturing teams. These teams manufacture clinical and commercial cellular therapy products in compliance with the Australian Code of Good Manufacturing Practice.

Throughout the week you will be involved in planning, coordinating and executing validation activities for various critical equipment and facility infrastructure that is used in producing and testing potentially life-saving therapies.

This is a Full-time Position, located at our new, state-of-the-art Melbourne facility, in the Peter MacCallum Cancer Centre on the edge of the CBD in Australia’s most dynamic biomedical precinct.

To be successful in this role 

CTPL is seeking candidates with a degree in life sciences or engineering to join our growing team in Melbourne. Preferred candidates will be able to demonstrate results and impact through:

Duties:

• Perform validation activities in accordance with the Quality Management System, Validation Master Plan and Validation procedures.
• Develop and execute IQ, OQ and PQ validation protocols.
• Maintain strong collaborative relationships with key internal stakeholders within Cell Therapies, building partners and external vendors to meet project deliverables.
• Participate in problem solving and identify continuous improvement opportunities to optimise validation activities.

Skills and Experience

• A relevant science or engineering tertiary qualifications and demonstrated experience in regulated environment, ideally within pharmaceutical industry.
• 2-3 years experience in validation, quality assurance or engineering-related role.
• 2-3 years experience in developing and execution of validation protocols for facility systems, processes, equipment and laboratory equipment.
• Sound understanding of the principles of Validation/Qualification
• Demonstrated knowledge of GMP, QMS and Risk Management and knowledge of industry guidance documents and standards focusing on qualification and validation principles and applications.
• Proficiency in writing procedural & technical documents, executing and completing validation protocol and repots
• Experience in a GMP regulated environment essential.
• A diligent and quality-driven approach.
• Excellent organisational and interpersonal skills including the ability to liaise and provide feedback to the relevant teams, and
• Ability to multitask and work autonomously as well as in teams.

This is a great opportunity for a driven, collaborative and curious professional to join an organisation with purpose, passion for excellence and the aspiration to be a global leader in cell and gene therapy.

At CTPL we are passionate about the work we do but equally passionate about our people. We want everyone to bring their true self to work. We support the wellbeing of our staff through mindfulness sessions, continuous improvement activities and 5 wellness days a year.

In applying, please provide a cover letter that addresses the key selection criteria. All applications must be submitted via SEEK.

* We will not be liable for any fees and cost associated with unsolicited CVs sent to us from recruitment agencies.