Process Engineer

Tech Recruit Australia; Sydney; On-site; AUD 110,000 - 150,000; Full time

Job summary

Infotech People is recruiting for a hands-on Process Engineer to support GMP biotech manufacturing in a highly regulated environment. You will work with Process, Automation, Quality, Maintenance and Operations teams to improve production reliability and scale-up.

The role focuses on process optimisation, troubleshooting and implementing practical improvements; familiarity with Siemens TIA Portal is required to investigate issues and make controlled changes on the floor. Sydney, NSW.

Qualifications

• Experience in GMP-regulated pharmaceutical/biotech manufacturing.
• Proficient with PLCs and Siemens TIA Portal for controlled changes.
• Degree in Chemical, Process, Mechanical, Biomedical or Mechatronics.
• Strong problem-solving and root-cause analysis abilities.
• Ability to document, validate and manage change control.

Responsibilities

• Support process optimisation, troubleshooting and CI initiatives across the facility.
• Identify improvement opportunities and lead end-to-end implementations.
• Investigate deviations, determine root causes and implement CAPAs.
• Collaborate with Automation, Maintenance, Quality and Operations teams.
• Review PLC logic and apply controlled changes via Siemens TIA Portal.
• Support commissioning, validation and change-control activities.
• Prepare technical documentation including SOPs, protocols and reports.
• Help develop scalable processes for growing manufacturing operations.
• Ensure safety, quality and GMP compliance in all activities.

Skills

GMP experience

Process engineering

Cross-functional collaboration

Troubleshooting

Documentation & validation

Education

Engineering degree (Chemical/Process/Mechanical/Biomedical/Mechatronics)

Tools

Siemens TIA Portal

Job description

Process Engineer – GMP Biotech Manufacturing | Siemens TIA Portal

Sydney, NSW | Permanent, full-time | On-site

Infotech People is recruiting for a high-growth biotechnology manufacturer operating in a highly regulated environment.

This is a hands-on Process Engineering role supporting process improvement, technical problem-solving and manufacturing scale-up. You will work closely with Process, Automation, Quality, Maintenance and Operations teams to improve production reliability and resolve real operational challenges.

This role will suit a proactive, well-rounded engineer who enjoys taking ownership. In a smaller, agile environment, you will not be confined to a narrow technical remit. You will be comfortable leading initiatives, working across functions and stepping into different areas when the business needs your expertise.

The opportunity

You will support the optimisation and reliable operation of complex manufacturing processes, investigate issues on the floor, and help deliver safe, practical improvements within a GMP environment.

This is not a pure automation role. However, you must be technically comfortable around PLCs and confident enough in Siemens TIA Portal to investigate issues and make controlled changes when required.

What you will be doing

• Support process optimisation, troubleshooting and continuous-improvement initiatives across the manufacturing facility.

• Identify opportunities for improvement and lead practical initiatives from investigation through to implementation.

• Investigate process deviations, identify root causes and contribute to corrective and preventive actions.

• Work with Automation, Maintenance, Quality and Operations teams to resolve equipment and process issues.

• Review PLC logic and make controlled changes using Siemens TIA Portal where required.

• Support commissioning, qualification, validation and change-control activities.

• Prepare and maintain technical documentation, including SOPs, risk assessments, protocols and reports.

• Help develop robust, scalable processes as the manufacturing operation grows.

• Ensure all work is completed with a strong focus on safety, quality and GMP compliance.

What you will bring

To be considered, you MUST HAVE:

• Experience working in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

• Practical PLC knowledge, including the ability to investigate and make controlled changes through Siemens TIA Portal.

• Process Engineering experience in a manufacturing, chemical, pharmaceutical, biotech or similarly regulated environment.

• A relevant engineering degree, such as Chemical, Process, Mechanical, Biomedical, Mechatronics or equivalent.

• Experience with process troubleshooting, root-cause analysis and continuous improvement.

• A sound understanding of documentation, validation and change control in a regulated setting.

• A proactive approach, with the confidence to identify issues, lead initiatives and bring the right people together to solve them.

• Broad technical curiosity and the flexibility to contribute beyond a narrowly defined role.

• The ability to work effectively across technical, operational and quality teams.

Experience in sterile manufacturing, biologics, batch processing or complex process plants will be highly regarded.