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:
Both roles offer the prospect 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.
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📌 GMP Process Engineer for Biotech & Pharma Scale-Up (Brisbane City)
🏢 PSC Biotech
📍 Brisbane City
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