Process Engineer

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

We are seeking an experienced engineer to support our manufacturing operations and drive continuous improvement by identifying opportunities for enhancement and implementing effective solutions.

About Us

Steritech is the leading and trusted contract sterilisation and decontamination processor in the Asia-Pacific region, and one of the largest worldwide. With operations in Victoria, New South Wales and Queensland, we provide Irradiation and ETO Gas processing services to the Agricultural, Fresh Produce, Healthcare, Biosecurity, Pet Products and Packaging industries.

We are a customer and employee focused business that provides clients with unique opportunities to open their business to new markets through innovative, technically advanced solutions.

About Your Role

You will be responsible for:

• Ongoing compliance with relevant legislation and standards governing our business, sterilisation and manufacturing operations.
• Studying and maintaining detailed reports and statements of quality assurance, quality control and process operational activities.
• Establishing standards and policies for installation, modification, quality control, testing, inspection and maintenance according to engineering principles.
• Maintaining the site’s products, components and equipment and process inspection, calibration and preventative maintenance programs.
• Ensuring compliance with safety and regulatory standards and driving continuous improvement initiatives.
• Assist in specification control and developing specifications, incoming QC and inventory monitoring of critical process consumables.
• Preparation of processed loads for dispatch and validation documentation.

About You

You will have a minimum 2 to 3 years’ experience in a quality function within a pharmaceutical, manufacturing, general healthcare or other highly regulated industry.

You will have:

• Qualifications in Mechanical, Electrical, or Biomedical Engineering or related discipline,
• Awareness of the general principles of sterilisation, validation, GMP manufacturing and related microbiology (desirable).
• Sound understanding of Good Manufacturing Principles and Quality Management System requirements (GMP PIC/S, ISO13485, ISO11137).
• Knowledge and experience in TGA Audits and/or other regulatory bodies.
• Sound judgement and decision-making abilities, often under pressure.
• Solid level of attention to detail.
• Effective communication skills and the ability to collaborate with internal teams and external stakeholders.

Successful candidates will be required to undergo a Pre-employment Medical check and Police Records check.

At Steritech we are dedicated to building a diverse, inclusive and authentic workplace. We are committed to a culture of diversity and inclusion that embraces and celebrates the differences and similarities within our people.

We strongly encourage applications from people regardless of their background. All suitable applicants will be considered regardless of age, ability, race, gender expression, sex, cultural background, spiritual beliefs or lived experience.

We accept applications from all people with the right to live and work in Australia.