Job Title

Who We AreCell 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 the delivery of commercial contracts to provide these highly personalised therapies to patients in Australia and the region.About the RoleWe 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 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 Australias most dynamic biomedical precinct.To be successful in this roleCTPL 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 optimize validation activities.Skills and ExperienceCandidates should have:A relevant science or engineering tertiary qualification and demonstrated experience in a regulated environment, ideally within the pharmaceutical industry.2-3 years of experience in validation, quality assurance, or engineering-related roles.2-3 years of experience developing and executing validation protocols for facility systems, processes, equipment, and laboratory equipment.Sound understanding of Validation/Qualification principles.Knowledge of GMP, QMS, Risk Management, and industry guidance documents focusing on qualification and validation principles.Proficiency in writing procedural and technical documents, executing, and completing validation protocols and reports.Experience in a GMP regulated environment is essential.A diligent and quality-driven approach.Excellent organizational and interpersonal skills, including the ability to liaise and provide feedback to relevant teams.The 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 organization with purpose, passion for excellence, and the aspiration to be a global leader in cell and gene therapy.At CTPL, we are passionate about our work and our people. We encourage everyone to bring their true self to work. We support staff wellbeing 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 costs associated with unsolicited CVs sent to us from recruitment agencies. #J-18808-Ljbffr