- Experience in TGA, GMP, PIC/S, regulated manufacturing
- Focus on safety, quality, risk and compliance
- Australian Citizenship is mandatory
About the company:
The company is a well-established government facility in the field of specialised nuclear medicines and is recognised worldwide. This is an excellent opportunity to join a busy manufacturing team, driving large scale manufacturing robustness, capability and continuous improvement projects, whilst leading root cause investigations into safety, quality and operational incidents.
About the role:
Evolve Scientific is seeking a Manufacturing Support Associate or Leader to ensure safety, quality, risk, and compliance in manufacturing processes. You will work closely with facility operators to identify hazards, implement CI projects, and lead audits, supporting the safe supply of Nuclear Medicine.
Ideal candidates have GMP manufacturing experience and leadership skills, ready to advance in a regulated, sterile environment.
Reporting to the Manufacturing Manager the role will entail:- Drive manufacturing robustness, capability, and continuous improvement projects.
- Develop, implement, and maintain manufacturing support documentation (e.g., process flow diagrams, instructions, risk assessments) in line with safety, quality, and regulatory standards.
- Provide technical support for efficient use of cGMP practices, QMS systems, and processes.
- Lead root cause investigations and execute corrective and preventative actions for safety, quality, and operational incidents.
- Monitor, trend, and report manufacturing compliance metrics, ensuring completion of change controls, corrective actions, deviations, and controlled documents.
Skills & experience: - Tertiary qualification in engineering, science or related discipline
- Significant experience in a GMP manufacturing environment is essential, preferably pharmaceutical manufacturing
- Experience in safety quality risk and compliance within regulated environments
- Proven skills in root-cause investigation, risk analysis, deviations, continuous improvements
- Knowledge and understanding of GMP, ISO, TGA, PIC/s guidelines preferable
- High level technical writing skills and highly competent in the use of MS Office Suite.
- Proven ability to influence stakeholders
- Australian Citizenship is a mandatory requirement for this role
To be considered for the more Leader role you must also have:- Strong leadership skills to manage, motivate, delegate, and drive team success in a matrix environment.
- Proven ability to identify and implement process improvements in manufacturing, enhancing efficiency, quality, and safety.
- Expertise in stakeholder engagement and autonomous decision-making, integrating insights from various experts to make sound judgments.
Culture/Benefits:- This is a full time permanent role.
- The salary will be dependent on experience: - $97k – 129k + 15.4 % super
- Public transport to the company is limited but plenty of parking is available.
- Monday to Friday, with one day WFH
How to Apply: If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Susan on susan.macleod@evolvescientific.com.au
Note: Applications for this role only accepted from Australian Citizens
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.