GMP Biotech Process Engineer – Scale-Up & Troubleshooting

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

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.