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Lavida Pharmaceuticals in Sydney seeks a Production Process Technician/Product Development Chemist to develop, optimise and maintain pharmaceutical manufacturing processes at Eastern Creek. Initial focus on gummy production with involvement across dosage forms and scale-up to commercial manufacturing.
The role covers equipment evaluation, process parameter optimization, validation, and continuous improvement across GMP-compliant operations, with collaboration among QA, Engineering and NPD teams.
As a Production Process Technician/Product Development Chemist, you will develop, optimise and maintain pharmaceutical and nutraceutical manufacturing processes at the Eastern Creek site in Sydney. With an initial focus on gummy production and involvement across other dosage forms(liquids, creams, cosmetics), you will support safe, reliable, efficient and GMP-compliant operations across equipment, formula, process systems, scale-up, validation and commercial manufacturing.
Key responsibilities
Develop, review and optimize manufacturing processes for gummy products and other pharmaceutical, nutraceutical and complementary medicine dosage forms.
Evaluate equipment, processing parameters, plant capacity, material flow and facility layouts to improve productivity, safety and product quality.
Develop process-flow diagrams, equipment specifications, operating parameters, engineering calculations and technical manufacturing instructions.
Provide engineering support across gummy manufacturing activities, including ingredient preparation, cooking, mixing, dosing, depositing, moulding, cooling, demoulding, curing, inspection and packing.
Optimize gummy manufacturing parameters such as temperature, solids content, viscosity, pH, cooking time, depositing conditions, cooling time and curing conditions.
Investigate process variability, product defects, production losses, yield issues, equipment constraints and technical risks, implementing sustainable engineering solutions.
Support process improvement across tablets, capsules, powders, granulation, sachet filling, effervescent products, liquids, suspensions, creams, semi-solids and packaging operations.
Coordinate the selection, specification, installation, modification, commissioning and qualification of manufacturing equipment and process systems.
Prepare and review User Requirement Specifications, technical specifications, equipment layouts, commissioning protocols and engineering change documentation.
Inspect plant and equipment, investigate recurring failures and contribute to preventive maintenance, spare-parts planning and equipment life-cycle management.
Improve Overall Equipment Effectiveness, throughput, yield, uptime and changeover performance using Lean manufacturing, Kaizen and root-cause analysis.
Develop proposals and business cases for plant improvements, automation and capital equipment, and verify that intended benefits are achieved.
Support new product introduction, laboratory-to-commercial scale-up, technology transfer, trial batches, validation batches and technical-transfer documentation.
Establish operating ranges and critical process controls in consultation with Quality and Engineering, ensuring processes are reproducible and meet approved product specifications.
Ensure equipment and processes comply with WHS legislation, engineering standards, TGA requirements, PIC/S GMP principles, environmental obligations and internal quality systems.
Prepare and maintain technical specifications, engineering reports, operating instructions, risk assessments and standard operating procedures.
Provide technical training and coaching to production personnel on critical process controls, equipment limitations and escalation procedures.
Collaborate with Production, Quality Assurance, Quality Control, Engineering, NPD, Validation, Warehouse and Supply Chain teams.
Liaise with equipment manufacturers, technical consultants, contractors and service providers, and provide engineering advice on capacity, risks, process performance and capital requirements.
Participate in customer, regulatory and certification audits when engineering or manufacturing-process expertise is required.
What we're looking for
A Bachelor's degree or higher qualification in Pharmaceutical, Nutrition, Manufacturing, Industrial, Mechanical, Chemical or Process Engineering, or a closely related discipline.
Professional experience in product development, process or manufacturing engineering.
Experience analyzing and improving manufacturing equipment, processes, capacity, and production performance.
Experience supporting equipment installation, commissioning, modification or qualification.
Experience in gummy, confectionery, food, pharmaceutical or other regulated process manufacturing is highly desirable.
Strong understanding of engineering risk assessment, root-cause analysis and continuous improvement.
Strong technical-report writing, data-analysis and problem-solving capabilities.
A practical, commercially responsible approach to engineering decisions, with strong communication, organization and time-management skills.
A commitment to GMP, hygiene, safety, product quality and continuous improvement.
Ability to work on site at Eastern Creek and comply with gowning, PPE, hygiene and controlled-area requirements.