|Job Type:||Full Time|
- Contribute to the establishment of a brand new cGMP facility
- Use your expertise in GMP standards and GMP recording systems
- Join CSIRO Manufacturing and make a difference by contributing to the delivery of new pharmaceuticals!
As the Pharmaceutical/Utilities Process Engineer, you will maintain the engineering side of CSIRO’s new cGMP Biologics facility as well as our current cGMP-like facility. In this diverse role, you will interact with other CSIRO engineers and ensure the facility certifications with the TGA/FDA are maintained.
The Advanced Biologics Manufacturing Facility is currently being built and is expected to be open by the end of 2021. The facility will produce biologics for Phase-I and Phase-II trials to assist in the progression of biologics such as vaccine and drug candidates into safe and effective pharmaceuticals that can be manufactured at scale using industry-relevant techniques.
- Maintaining the engineering aspects of the cGMP Biologics and cGMP-like facilities and contributing to the maintenance of other laboratories and facilities as required.
- Ensuring all engineering aspects of TGA/FDA certifications are maintained.
- Inducting and managing all contractors performing maintenance works on the cGMP facility.
- Providing a 24/7 response for the cGMP facility and be available within 2 hours' notice for emergency maintenance and repairs.
- Documenting procedures and training other CSIRO engineers in systems and processes.
Location: Melbourne (Clayton) VIC
Salary: AU$83k - AU$94k plus up to 15.4% superannuation
Tenure: Specified term of 18 months
- A relevant trade certificate/diploma/bachelor's degree or equivalent relevant work experience in engineering.
- Demonstrated experience in GMP standards, including GMP recording systems.
- Proven experience with operation, management and maintenance of:
- Highly purified pharmaceutical water systems;
- HVAC systems;
- Pharmaceutical gases systems such as compressed air and nitrogen;
- Clean steam and plant steam systems.
- The proven ability to work effectively as part of a team and carry out tasks autonomously in support of scientific research.
- Good communication skills and a history of cultivating productive working relationships with stakeholders.
- To be willing and able to provide a 24/7 response for the cGMP facility and be available within 2 hours' notice for emergency maintenance and repairs.
For full details about this role please view the Position Description
The successful applicant will be required to obtain and provide a National Police Check or equivalent.
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
We are working hard to recruit diverse people and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish. Diversity and Inclusion Strategy
We are committed to the safety and wellbeing of all children and young people.
At CSIRO, Australia's national science agency, we solve the greatest challenges through innovative science and technology.
Join us and start creating tomorrow today!
Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role.
29 November 2020 11:00pm AEDT