Process Engineer

Steritech; Melbourne; Vor Ort; AUD 90.000 - 120.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality mindset

Regulatory awareness

Analytical thinking

Effective communication

Ausbildung

Engineering degree (Mechanical, Electrical or Biomedical)

Tools

GMP knowledge

ISO13485 / ISO11137 familiarity

Jobbeschreibung

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

• 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.