GMP Quality & Process Engineer (Sterilisation)

Steritech; Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

Steritech, a leading contract sterilisation and decontamination processor in the Asia-Pacific region, is seeking an experienced engineer to support manufacturing operations and drive continuous improvement in Victoria, Australia.

The role focuses on maintaining QA/QC, ensuring GMP compliance, and supporting calibration, maintenance and regulatory audits. The ideal candidate holds an engineering degree and 2–3 years in a regulated environment, with strong communication and collaboration skills.

Qualifications

• Minimum 2–3 years experience in a quality function within a regulated industry.
• Qualifications in Mechanical, Electrical or Biomedical Engineering or related discipline.
• Awareness of sterilisation, validation, GMP manufacturing and related microbiology (desirable).
• Strong understanding of GMP PIC/S, ISO13485, ISO11137; knowledge of TGA audits or other regulators.

Responsibilities

• Maintain compliance with legislation and standards governing our business and operations.
• Study and maintain detailed QA/QC and process operation reports.
• Establish standards and policies for installation, modification, QC, testing, inspection and maintenance.
• Maintain site products, components and equipment and calibration programs.
• Ensure safety compliance and drive continuous improvement initiatives.
• Assist in specification control, incoming QC and inventory monitoring of critical consumables.
• Prepare processed loads for dispatch and validation documentation.

Skills

Quality mindset

Regulatory awareness

Analytical thinking

Effective communication

Education

Engineering degree (Mechanical, Electrical or Biomedical)

Tools

GMP knowledge

ISO13485 / ISO11137 familiarity

Job description

Steritech, a leading contract sterilisation and decontamination processor in the Asia-Pacific region, is seeking an experienced engineer to support manufacturing operations and drive continuous improvement in Victoria, Australia.

The role focuses on maintaining QA/QC, ensuring GMP compliance, and supporting calibration, maintenance and regulatory audits. The ideal candidate holds an engineering degree and 2–3 years in a regulated environment, with strong communication and collaboration skills.