Process Engineer (GMP) Brisbane (Brisbane City)

Brisbane, Australia | Posted on 03/20/2026 We are seeking Process Engineers to support ongoing process development and manufacturing scale‑up activities within a GMP‑regulated setting . 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: 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 optimi s ation 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 medicaldevice , 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. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rvf1w