Responsibilities
- Support the quality of the manufacturing and validation processes through the Company's management systems: Quality, HR, OHS.
- Develop and maintain manufacturing processes by analysing product requirements, researching, designing, modifying, and testing manufacturing methods and equipment.
- Evaluate processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
- Assure product and process quality by designing testing methods, testing finished product and process capabilities, establishing standards, confirming manufacturing process.
- Improve manufacturing efficiency by analysing and planning work flow, space requirements and equipment layout.
- Develop manufacturing technical capabilities and skills to ensure ongoing process requirements can be effectively achieved and continually improved.
- Provide manufacturing decision making information by identifying cost saving initiatives in labour and material costs and consumption and process improvements.
- Keep equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures.
- Prepare technical documentation such as SOPs, safety programmes, validation protocols, technical reports, engineering calculations, change controls and other documentation as required.
- Maintain and present when required appropriate technical data to internal / external audit and inspection groups and Customers.
- Be a member of the cross-functional team responsible for ensuring that all Customer requirements are consistently being achieved and/or exceeded.
- Be flexible in supporting the production process and third party contractors to meet the business and facility needs.
- Report to Plant Manager or designated representative.
Requirements
- Ordinary Degree (Level 7) in Engineering or Technical Science.
- Previous experience in a medical manufacturing environment (ideally 3+years).
- Knowledge of ISO, FDA, GMP and six sigma requirements.
- PLC Programming desirable.
- Process Validation experience desirable.
- Professional interpersonal, self-presentation and communication skills.
- Demonstrate sound methodology in faultfinding techniques.
- Capability to take the lead in resolving technical issues.
- Understanding of Validation processes and regulated environments.
- Strong leadership skills with ability to motivate and direct.
- Positive team working approach and adherence to Policies and Procedures.
- Focus on Quality, Customer Satisfaction and continual improvement.
