About the company:The company is a well-established government facility in the field of specialised nuclear medicines and is recognised worldwide. They host Australia's most significant research infrastructure, benefiting thousands of scientists annually. Nuclear Medicine manufactures and sells radiopharmaceuticals and radiochemical products, operating to GMP, ISO, ARPANSA, and TGA regulations.About the role:Evolve Scientific is seeking a Process Performance Engineer Associate or Leader to improve process performance within manufacturing. You will work closely with operators to implement CI projects, write technical reports, conduct process validations, supporting the safe supply of Nuclear Medicine. Ideal candidates have strong GMP manufacturing experience and leadership skills, ready to advance in a regulated, sterile environment.Reporting to the Process Performance Manager the role will entail:Develop and maintain process performance frameworks (risk assessments, control strategies, validation documentation) in line with safety, quality, and regulatory standards, utilising QMS processes.Provide validation expertise to ensure manufacturing equipment, systems, processes, and cleaning are validated per GMP requirements.Lead investigations into performance, quality, and operational incidents, providing root cause analysis in technical reports.Monitor, trend, and report process performance metrics.Provide technical support and impact assessments for process changes, investigations, and continuous improvements.Foster a supportive environment of communication, consultation, and continuous improvement within the Manufacturing team.Ensure compliance with ARPANSA regulations, TGA licensing, Nuclear Medicine procedures, and WHS standards. Skills & experience: Tertiary qualification in engineering, science or related disciplineExperience in GMP manufacturing (validation preferred), with sterile or pharmaceutical manufacturing and/or high reliability environments highly regarded.Understanding of regulatory standards and guidelines (e.g. GMP, TGA, PIC/S).Proven ability to identify and implement process improvements to enhance efficiency, quality, and safety.Skills in root-cause investigation, risk analysis, deviations, and continuous improvements.High-level technical writing skills and proficiency in MS Office Suite.Proven ability to influence stakeholders.Australian Citizenship is a mandatory requirement for this roleTo be considered for the 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 % superPublic transport to the company is limited but plenty of parking is available.Monday to Friday, with one day WFHHow 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 CitizensWith 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.
