Position details
Position title: Laboratory Technician
Position classification: APS 5 Equivalent
Start date: ASAP
End date: 12 months
Possibility of extension: Up to 18 months
Hours: Full-time (37.5 hours per week)
Location: Canberra – Fairbairn
Domestic travel required: No
Eligibility Requirements: Australian Citizenship is essential
Background information on Section and Branch
The Biomaterials & Engineering Section performs safety and performance testing across electrical, electronic, software, cybersecurity, mechanical, physical, and biological domains, primarily focussed on medical devices and other therapeutic goods.
Our work protects lives by helping ensure medical devices are safe, reliable and fit for purpose — every device matters, every test counts. Through rigorous laboratory testing, technical investigation and standards development, we build trust in Australia's health system and support regulatory decision making across the product lifecycle.
The Section designs and conducts laboratory and technical evaluations, supports investigations into adverse events and product issues, and provides expert engineering and scientific advice for both pre market and post market regulatory activities. We also contribute to the development of national and international standards and provide technical services and capability support across the Laboratories Branch.
Our work enables evidence based responses to emerging public health risks, strengthens the Regulator's ability to independently investigate safety and performance concerns, and reinforces public confidence in the quality of therapeutic goods supplied in Australia.
Duties of position
Responsibilities include:
* Conducting testing, analysing data and results, and reporting on scientific and/or engineering based technical investigations of medical devices to ensure they meet regulatory requirements, using a risk‐based regulatory approach.
* Supporting scientific and/or engineering‐based testing projects for medical devices, including contributing to the preparation of project proposals and testing plans.
* Contributing to the development and review of testing methods, SOPs, spreadsheets, and programs for laboratory instruments to establish their reliability and validity for use.
* Undertaking testing and calibration of laboratory instruments and tools, identifying technical faults, and preparing short technical reports documenting findings and recommendations.
* Monitoring laboratory inventory to ensure the availability of required consumables and the effective operation of laboratory instruments and equipment.
If undertaking container safety evaluations, responsibilities include:
* Undertaking secondary evaluations of container closure systems for drug products and drug substances following internal guidelines, ensuring compliance at each evaluation stage.
* Coordinating evaluation cases amongst the Container Safety Evaluation team to ensure case information aligns with records in the primary evaluation database.
* Contributing to the development and review of SOPs, templates and internal guidance for conducting evaluations of container closure systems.
Key Capabilities
* Knowledge of, or ability to learn, quality‐controlled laboratory testing concepts, including working within established procedures, equipment qualification, and fit‐for‐purpose test methods.
* An ability to read, understand and apply relevant technical scientific and/or engineering standards (e.g. mechanical, electrical, materials, biological or computational systems).
* A capacity to objectively analyse qualitative and quantitative data, and to provide advice on this basis.
* A strong attention to detail, and desire to produce high quality, robust, and unbiased laboratory results.
* An understanding of and/or a capacity to work within a quality management system such as ISO 9001, 17025, or 13485.
* Communication skills including the ability to take on constructive feedback, willingness to learn and grow within the role.
* Proficient in effectively communicating project details to internal teams, with the ability to employ both technical language and accessible clear explanations.
* An ability to generate clear scientific or engineering reports with guidance, based on established methodologies and laboratory work conducted by themselves or their team members.
* The ability to build and sustain positive working relationships with team members.
* For container safety evaluations: an understanding and ability to learn relevant scientific principles and standards required to perform and complete evaluation of container systems for drug products and substances, based on internal evaluation guidelines.
Mandatory requirements
Relevant qualifications or demonstrated equivalent experience in Engineering, Science, Technology or laboratory testing relevant to medicines, medical devices, or regulated products.
Desirable
A certificate, diploma or degree in Engineering, Science, Technology or related fields relevant to medicines, medical devices, or laboratory testing.
Experience working within a regulated or quality‐managed laboratory environment.
Experience working in fields related to medicines, medical devices or other regulated industries.
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