The Role
Join a dynamic pharmaceutical manufacturing environment where you will play a key role in improving manufacturing performance, equipment reliability and operational efficiency.
As a Manufacturing Engineer, you will lead and support capital and continuous improvement projects across the manufacturing area while providing day-to-day technical support to Production and Maintenance teams. You will work closely with cross-functional stakeholders to troubleshoot equipment and process issues, optimise manufacturing performance and ensure engineering activities are delivered safely and in compliance with pharmaceutical regulatory requirements.
The role will also contribute to equipment commissioning and qualification, New Product Introductions (NPI), reliability initiatives and broader engineering projects under the direction of the Engineering Manager.
About Mayne Pharma
Mayne Pharma is a global pharmaceutical company offering end-to-end pharmaceutical development and manufacturing to customers around the world. Our heritage makes us one of the most well-known and respected pharmaceutical companies in Australia.
Mayne Pharma Australia is passionate about bringing globally valued pharmaceuticals to Australian patients and consumers. Our values of Passion, Integrity, Accountability, Creativity, Empowerment and Agility are the foundation for everything we do.
Why Join Us?
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Attractive remuneration packages
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Professional Development
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Mayne Perks: Enjoy exclusive discounts and savings
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Community Service
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Recognition and Team Events
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Exclusive Health Insurance Benefits
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Well-being Program
Here’s where you come in!
Your responsibilities, at a glance, will include:
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Lead and support capital and continuous improvement projects, including project scoping, cost estimates, timelines, execution and reporting, ensuring delivery on time and within budget.
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Provide day-to-day technical support to Production and Maintenance teams, troubleshooting equipment and process issues to minimise disruption to manufacturing operations.
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Lead the commissioning of new plant, equipment and manufacturing processes and support associated qualification and validation activities, including IQ/OQ/PQ.
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Prepare and manage GMP documentation associated with engineering projects, including change controls, risk assessments, commissioning documentation and technical records.
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Support and lead root cause investigations into equipment and process-related issues and implement appropriate corrective and preventive actions (CAPA).
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Drive continuous improvement initiatives focused on equipment reliability, operational efficiency, process robustness and manufacturing performance.
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Apply Lean Manufacturing and Six Sigma principles to identify waste, reduce variability and optimise equipment and manufacturing processes.
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Collaborate on New Product Introductions (NPI) and commercial product transfers, ensuring equipment capability and technical readiness.
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Support the development and optimisation of Preventive Maintenance programs to improve equipment uptime and reliability.
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Utilise Enterprise Asset Management (EAM)/CMMS systems and equipment data to analyse asset performance and support site reliability initiatives.
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Participate in the design and development of manufacturing processes, production flows, equipment improvements and automation opportunities.
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Ensure engineering and GMP documentation, including SOPs, maintenance procedures, P&IDs and equipment specifications, remains current, accurate and compliant.
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Support cross-functional teams during internal audits and regulatory inspections, including TGA and FDA inspections.
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Collaborate with suppliers and contractors on equipment design, specification, procurement, installation and commissioning.
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Provide technical training and support to operators and Maintenance team members on new equipment, processes and associated safety requirements.
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Support environmental sustainability initiatives, including energy reduction and waste minimisation projects.
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Ensure all engineering activities are undertaken in accordance with GMP, WHS, environmental requirements and company quality systems.
Promote a culture of operational excellence, continuous improvement, safety and regulatory compliance. -
Perform other duties considered appropriate for the position, as required.
You need to tick these boxes
We select applicants based on capability and aptitude, while also placing a strong emphasis on cultural fit. You will need a positive mindset, a practical approach to problem solving and a willingness to take ownership of your performance.
You will also bring:
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Tertiary qualifications in an Engineering discipline.
Relevant engineering experience within pharmaceutical, food and beverage, medical device or another highly regulated manufacturing environment. -
Experience supporting manufacturing equipment, capital projects, commissioning and/or continuous improvement activities.
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An understanding of GMP requirements and engineering activities within a regulated manufacturing environment.
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Strong analytical and problem-solving skills, with the ability to investigate equipment and process issues and develop practical solutions.
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A driven, self-motivated and independent approach, with the ability to work effectively with minimal supervision.
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Excellent communication and interpersonal skills, with the ability to work collaboratively across Production, Maintenance, Quality and other functional teams.
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Strong attention to detail, particularly in relation to engineering documentation, change control and GMP requirements.
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Experience with Lean Manufacturing, Six Sigma, EAM/CMMS systems, equipment qualification or validation would be highly regarded.
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