Process & Commissioning Engineer Melbourne

About the Role We are seeking an experienced Process & Commissioning Engineer to support a 12‑month manufacturing project based in Melbourne. This role will play a critical part in upgrading and enhancing GMP manufacturing operations, ensuring successful integration of new equipment and processes within an established facility. Working within a regulated environment, you will lead and execute commissioning, qualification, and process optimisation activities, ensuring minimal disruption to ongoing operations while delivering project milestones. This position is ideal for engineers who thrive in live site environments, balancing project delivery with operational demands. Key Responsibilities Lead and execute commissioning activities for new and upgraded manufacturing equipment. Support process development and optimisation of existing manufacturing operations to improve performance and reliability. Coordinate closely with project, operations, engineering, and quality teams to ensure seamless integration of new systems into production. Develop and execute commissioning plans, protocols, and documentation in line with GMP requirements. Support equipment qualification activities (IQ/OQ/PQ) and ensure readiness for validation and commercial use. Identify and resolve process and equipment issues during commissioning and early production phases. Assist with technical transfer activities, including updating process documentation, SOPs, and batch records. Contribute to risk assessments, HAZOPs, and change control processes associated with facility upgrades. Drive continuous improvement initiatives to enhance process efficiency, compliance, and operational capability. Requirements Required Qualifications & Experience Bachelor’s degree in Engineering (Chemical, Process, Mechanical, Biomedical, or related discipline). 3+ years’ experience within GMP-regulated industries (pharmaceutical, biotechnology, or medical devices). 2+ year proven experience in commissioning and qualification of manufacturing equipment. Strong understanding of GMP requirements, quality systems, and validation principles. Experience supporting equipment qualification (IQ/OQ/PQ) and process validation activities. Demonstrated experience working within operational manufacturing environments. Strong problem-solving skills with the ability to work independently in fast-paced project environments. Additional Requirements This role is site-based and will require the successful candidate to work on-site in Melbourne for the duration of the project. Due to project and operational requirements, there may be a need to support shift work, including evenings, nights, and/or weekends as required.