GMP Process Engineer | Sterilisation & QA

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

Job summary

Steritech Australia is seeking an experienced engineer to support our manufacturing operations and drive continuous improvement by identifying opportunities for enhancement and implementing effective solutions. You will ensure compliance with GMP manufacturing standards, maintain QA/QC documentation, and collaborate with internal teams to optimise processes.

A mechanical/electrical/biomedical engineering background and 2–3 years in a regulated setting are required.

Qualifications

• Minimum 2–3 years’ experience in a quality function within a regulated industry (pharma/manufacturing/healthcare).
• Strong understanding of GMP/quality systems and regulatory requirements.

Responsibilities

• Ensure ongoing compliance with legislation and standards governing sterilisation and manufacturing operations.
• Maintain quality assurance/control documentation and process reports.
• Establish standards and policies for installation, modification, testing, inspection and maintenance.
• Oversee calibration and preventative maintenance programs for equipment and components.
• Drive continuous improvement initiatives and support regulatory audits.

Skills

Effective communication

Attention to detail

Judgement & decision-making

Cross-functional collaboration

Education

Mechanical, Electrical, or Biomedical Engineering

Job description

Steritech Australia is seeking an experienced engineer to support our manufacturing operations and drive continuous improvement by identifying opportunities for enhancement and implementing effective solutions. You will ensure compliance with GMP manufacturing standards, maintain QA/QC documentation, and collaborate with internal teams to optimise processes.

A mechanical/electrical/biomedical engineering background and 2–3 years in a regulated setting are required.