Are you an experienced Validation Specialist looking to make an impact in a growing organisation? This is a rare opportunity to join an established biotech organistaion at an exciting stage of expansion, where you will play a key role in shaping validation processes and supporting the introduction of new products. Following a recent restructure, the company is seeking a hands-on validation professional to establish best practices and lead validation activities across R&D, QA, and Production. You will work closely with teams that genuinely collaborate, value open communication, and take pride in delivering high-quality outcomes. Key Responsibilities Plan and execute validation projects in line with the Validation Master Plan. Develop and review validation protocols, reports, and supporting documentation. Perform risk assessments, gap analyses, and support change control and deviation processes. Coordinate technical transfers between QA, R&D, and Manufacturing. Ensure validation activities meet cGMP, regulatory, and internal SOP requirements. Act as a subject matter expert for validation during audits and inspections. About You Minimum 3 years hands-on validation experience within pharmaceutical, biotech, or medical device manufacturing. Strong understanding of validation principles, GMP, and regulatory frameworks. Skilled in process and equipment validation, risk assessment, and documentation. Confident communicator who can influence, question processes, and work collaboratively. Able to work independently and produce validation documentation from start to finish. Why Join? Be part of a supportive and down-to-earth QA team that values initiative and teamwork. Opportunity to take ownership of validation strategy and drive process improvements. Work with a company introducing exciting new products and investing in growth. If you are ready to step into a high-impact role where your validation expertise will shape future success, I would love to hear from you. This is a full-time position based in the office. For any additional information, please contract Grace Bitodi at gbitodi@onqrecruitment.com.au or 029431 2540.
