Location: Melbourne, VIC, AU
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- Expertise in engineering projects within the Biomedical Manufacturing program
- Leadership in engineering activities within the Regulated Biomanufacturing group
- Join CSIRO - Australia's leading scientific research organisation
Many of CSIRO's innovations were once considered impossible. Fast WiFi, Aerogard insect repellent and the plastic Australian banknote, to name a few. Until someone, just like you, joined us and took on the challenge. We’re recruiting inventors, innovators and change makers. Join Team CSIRO and help make the impossible possible.
CSIRO’s Manufacturing Business Unit brings together multi-disciplinary scientific and engineering capabilities using world-class infrastructure to partner with industry in order to develop innovative products and processes to allow Australian manufacturers to be globally competitive and environmentally sustainable. The role of the Pharmaceutical Project Engineer will be to maintain the engineering side of CSIRO’s regulated biomanufacturing projects including the current accredited manufacturing facility.
As a Pharmaceutical Engineer you will be accountable to maintain the engineering side of CSIRO’s Biomedical Manufacturing projects, as part of the National Vaccine and Therapeutics Laboratories including the current accredited manufacturing facility and QC Laboratories. You will be exposed to several existing and new projects on site including CSIRO biologics manufacturing facility that will produce investigational materials for Phase-I and Phase-II trials to assist in the progression of biologics such as vaccines and other biotherapeutic drugs candidates into safe and effective pharmaceuticals that can be manufactured at scale using industry-relevant techniques.
Your duties will include:
- Planning, coordinating, and supporting technical and engineering activities within the Biomedical Manufacturing program.
- Providing leadership to engineering activities within the Regulated Biomanufacturing group.
- Supporting engineering projects and overseeing efficient project execution and providing guidance to other engineers or project leaders when needed.
- Establishing project specifications by studying facility design, customer requirements, and performance standards and completing technical studies.
- Providing timely engineering solutions to problems associated with project assignments.
- Assisting with technical evaluations/project tasks on capital projects from concept stages, through procurement, installation, start-up and commissioning/qualification.
- Playing a key role in negotiations with external bodies and vendors.
- Supporting regulatory audits by presenting Engineering related information to auditors. Maintain facility documentation in a state of inspection readiness.
- Undertaking a wide variety of tasks with varying degrees of technical complexity.
Location: Clayton, Melbourne VIC
Salary: AU$105k - AU$114k plus up to 15.4% superannuation
Tenure: Indefinite / Full time
To be considered you will need:
- Relevant bachelor’s degree or equivalent relevant work experience in Engineering.
- Prior experience of providing technical support to the design, development, and implementation of new engineering projects.
- Prior experience with operation, management and maintenance of pharmaceutical manufacturing plant equipment including:
- Highly purified pharmaceutical water systems
- HVAC systems
- Pharmaceutical gas systems such as compressed air and nitrogen
- Clean steam and plant steam systems
- Building and Equipment alarm systems
- The proven ability to work effectively as part of a team and carry out tasks autonomously in support of scientific research.
- Proven written and oral communication skills and the ability to cultivate productive working relationships with internal and external stakeholders.
- A history of professional and respectful behaviours and attitudes in a collaborative environment.
- Demonstrated experience in a regulated environment with experience of GMP standards, including GMP recording systems.
- Experience with implementation and management of equipment calibration and preventive maintenance procedures and systems.
- Experience in regulatory audits and presenting engineering related information to auditors.
- Good understanding of maintaining GMP records and documents.
For full details about this role please review the Position Description.
Applications for this position are open to Australian/ New Zealand citizens and Australian permanent residents only. Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements.
Flexible Working Arrangements
We work flexibly at CSIRO, offering a range of options for how, when and where you work.
Diversity and Inclusion
We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish.
At CSIRO Australia's national science agency, we solve the greatest challenges through innovative science and technology. We put the safety and wellbeing of our people above all else and earn trust everywhere because we only deal in facts. We collaborate widely and generously and deliver solutions with real impact.
CSIRO is committed to values-based leadership to inspire performance and unlock the potential of our people.
Join us and start creating tomorrow today!
How to Apply
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 February 2024, 11:00pm AEDT
We strongly encourage you to apply early as we will be reviewing applications as they come through. CSIRO reserves the right to withdraw this ad prior to the closing date, if required.