Process Engineer (GMP) Brisbane

About the Role We are seeking Process Engineers to support ongoing process development and manufacturing scale‑up activities within a GMP‑regulated environment. This role will play a key part in ensuring production readiness by supporting the startup of new manufacturing equipment, optimising existing processes, and enabling a smooth transition to commercial operations. The successful candidates will bring hands‑on experience in equipment and process startup, with exposure to aseptic and automated systems within medical device, biotechnology, or pharmaceutical environments. This position is available as: One 12‑month contract One 6‑month contract Both roles offer the opportunity to work on critical manufacturing and process development initiatives in a regulated setting. Key Responsibilities Lead and support process development activities for new and existing manufacturing processes. Execute and document startup, commissioning, and optimisation of manufacturing lines and equipment for GMP use. Collaborate with cross-functional teams to ensure processes are compliant with GMP standards and meet operational needs. Assist with tech transfer activities, including drafting and reviewing process documentation and procedures. Support the development and implementation of automation processes within aseptic or controlled production environments. Troubleshoot process issues and contribute to continuous improvement initiatives. Work closely with site engineering, operations, and quality teams to ensure delivery of project milestones. Provide input into process risk assessments, validation activities, and equipment readiness. Requirements Required Qualifications & Experience Bachelor’s degree in Engineering (Chemical, Mechanical, Biomedical, Process Engineering, or related discipline). 2 + years experience in medical device, biotech, pharmaceutical, or similar regulated GMP industries. Proven experience in process development within a GMP manufacturing environment. Demonstrated experience starting up or bringing online manufacturing equipment or processes for GMP operations. Strong understanding of GMP, quality systems, and regulated industry expectations. Experience in aseptic processing and/or development of automated manufacturing lines. Excellent problem-solving skills and ability to work independently in a fast-paced environment. Preferred Experiance Previous tech transfer experience within a GMP setting. Experience with highly automated or semi-automated manufacturing lines. Exposure to scaling up early-stage manufacturing processes.