My client is a busy biotechnology manufacturer specialising in the field of custom diagnostics. Their state-of-the-art facility is GMP and ISO 13485 regulated, whilst also having the agility to customise their manufacturing processes to meet additional regulatory requirements.
Due to strong growth, they currently require a Production Technician to join the team. The Production Technician will be involved in analytical / QC activities, all stages of the manufacturing process, and some facility management. Work on existing products along with assisting the introduction of new ones will also be part of the role.
The Production Technician role will involve:
- Play an integral role in biological product manufacture - Accurately weighing out and adding raw materials to vessels, and measuring and adjusting pH according to SOP instructions
- Cultivation of micro-organisms for antigen production
- In-process and final product QC testing
- Calibrating, maintaining and validating manufacturing equipment and facility
- Review of batch process sheets and SOPs, ensuring they are up-to-date and accurate
- Providing support to inwards and outwards goods process - Inspection, testing, proof checking, data entry (SAP), packing and shipping of products
The Successful Candidate will possess:
- Bachelor of Science or related
- Ideally a minimum of 3 years working in a medical device manufacturing environment
- Experience working within a GMP, ISO 9001 + ISO 13485 regulated environment
- Experience with technical writing - SOPs and BPSs
- Strong computer skills - Experience working with SAP highly advantageous
- Experience working in a cleanroom
- Excellent communication skills - Both written and verbal
- Ability to work effectively in a busy manufacturing environment
Questions can be directed to Leah Creswick at Fuse Recruitment Melbourne on 0478 193 170.
Please apply with your CV and covering letter in Word format, not PDF.