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Process & Commissioning Engineer Melbourne - PSC Biotech
Software Engineer
Process & Commissioning Engineer to lead GMP equipment integration, qualification, and process optimisation for a 12‑month manufacturing upgrade in Melbourne, driving seamless operations and regulatory compliance.
About the role
Key Responsibilities
- Lead commissioning, qualification, and validation of new manufacturing equipment and processes within a GMP‑regulated facility.
- Develop and execute detailed commissioning plans, ensuring minimal disruption to existing operations.
- Collaborate with cross‑functional teams to integrate equipment, troubleshoot issues, and optimise process performance.
- Document all activities, produce qualification reports, and maintain compliance with industry standards and regulatory requirements.
- Support continuous improvement initiatives, identifying opportunities for process efficiency and cost reduction.
Requirements
- Proven experience as a Process or Commissioning Engineer in a GMP manufacturing environment.
- Strong knowledge of qualification (IQ/OQ/PQ) processes and documentation.
- Excellent project management skills with the ability to coordinate multiple stakeholders.
- Effective communication skills and a proactive problem‑solving mindset.
Skills
process engineering