- Immerse Yourself in an Inclusive Culture
- Use your Skills and Make an Impact on CSIROs Manufacturing!
- Join CSIRO - Australia's Premier Science and Technology Research Organisation
The cGMP Technicians will be involved with CSIRO’s new cGMP pilot scale facility in the production of biologics for clinical trials (Phase 1 and beyond). Our clients will include Australian and overseas researchers and biotech and biopharmaceutical organisations, supporting the development of new biologics and growing the biotech industry. The cGMP Technicians will work on either upstream processing (media and reagent preparations, cell culture, scaling up to stirred tank bioreactors, filtration), or downstream processing (chromatography, viral reduction, tangential flow filtration), or fill and finish.
Your duties will include:
- Participating in manufacturing activities to meet production schedules, which will require weekend work.
- Performing upstream or downstream processing activities in clean room conditions.
- Adhering to the requirements of the Quality Management System (QMS) and Pharmaceutical Quality System (PQS).
- Accurate and timely completion of quality records.
- Identifying and reporting quality events in a timely manner according to procedure. Participating in investigations related to quality events (OOS, deviations, non-conformance).
- Participating in process reviews, CAPA and risk assessments.
- Reviewing other quality and process documents under the QMS/PQS.
- Contributing to the maintenance of the facility (cleaning and technical sanitisation, environmental monitoring, ordering).
- Assisting in the commissioning, validation and re-validation of equipment.
- Contributing to audits by clients or regulatory bodies.
- Under technical direction undertaking experiments, laboratory analyses or technology development activities (some non-routine) using a range of techniques, often working on a numerous parallel and competing tasks.
Duties (additional for CSOF4):
- Leading investigations related to quality events (OOS, deviations, non-conformance).
- Drafting quality and process documents under the QMS/PQS.
- Overseeing the activities of less experienced staff and provide guidance on experimental/ technological techniques and protocols.
- Direct experiments, laboratory analyses or technology development activities (some non-routine) using a range of techniques, often working on a number of parallel and competing tasks.
Location: Clayton, VIC
NOTE: The appointees may be required to work occasionally at Parkville, or at non-CSIRO sites elsewhere in Melbourne (Parkville or Broadmeadows).
Salary: AU$63,594 to AU$80,937 pa + up to 15.4% superannuation (CSOF3)
AU$83,687 to AU$94,679 pa + up to 15.4% superannuation (CSOF4)
NOTE: The positions are offered across two levels, the appointment level will be determined by the qualifications, skills and relevant experience of the successful candidates.
Tenure: Indefinite (Full-time)
To be successful you will need:
- Relevant bachelor’s degree or equivalent relevant work experience in Cell Biology, Biotechnology, Biochemistry, Chemical Engineering or Process Engineering.
- Extensive experience with sterile techniques.
- A current Australian driver’s licence.
- Computer literacy and familiarity with MS Office applications.
- Demonstrated track record of working collaboratively within a team to achieve results.
- Ability to use judgement to select the best option for improving performance (better yields, higher quality, improved client satisfaction).
Additional for CSOF4:
- Demonstrated competence in drafting technical documents, especially those associated with QMS.
- Evidence of experience in leading and directing projects.
Ability to investigate underlying issues of complex problems and develop the most appropriate response by adapting, creating and testing alternative solutions.
For details about who to contact and for more information please view the Position Description
CSIRO’s Commitment to Diversity
We’re working hard to recruit diverse people and ensure all our people feel supported to do their best work and empowered to let their ideas flourish.
Flexible Working Arrangements
We work flexibly at CSIRO, offering a range of options for how, when and where you work. Talk to us about how this role could be flexible for you. Balance
At CSIRO you can be part of helping to solve big, complex problems that make a real difference to our future. We spark off each other, learn from each other, trust each other and collaborate to achieve more than we could individually in a supportive, rewarding, inclusive and truly flexible environment.
To apply online, please provide a CV and letter outlining your suitability and motivation for the role, including an address of the essential criteria outlined in the Position Description.
23:59 AEDT 22nd October, 2020