- Perform Commissioning & troubleshooting / process activities on filling lines
- Pharmaceutical manufacturing project located in the Northern Suburbs
- 6 - 9 month contract (possible extension)
Our client is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, servicing the pharmaceutical, medical device, biotechnology and animal health industries
With offices located worldwide, they offer a comprehensive service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, creating solutions that are proven to be a winning combination for global corporations, as well as small and medium sized companies.
We are seeking a Filing Line Expert to work on a 6 – 9 month project, with experience in commissioning and troubleshooting machinery and equipment for a pharmaceutical company located in the northern suburbs.
You will be responsible for:
- Commissioning and troubleshooting during Startup + Debug phase of the filling line
- Set-up and tuning of machine parameters
- VHP cycle development
- Management of qualification and test plans according to specific technical requirements, requirements-testing traceability matrixes and design qualification and summary reports
- Drafting, verification and execution of protocols and qualification test (FAT, SAT, IQ, OQ, PQ)
- Installation, operational and performance qualification protocols for equipment (e.g.: Filling Line, Vial Washer, Tunnel, Capping Machine), according to the current internationally recognised guidelines (e.g.: ISPE, GAMP)
- Development of project validation master plans for new sites implementation including detailed Gantt charts with resources workload evaluation (advanced knowledge of Microsoft Project requested)
- Risk-based process analysis according to international methodologies (e.g.: FMEA, HACCP)
- Creation of calibration and maintenance plans and related instructions
- Standardization of operating procedures
- Calibration of devices (automatic and manual)
About you:
- Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)
- Minimum of 5 years of experience in Pharmaceutical Sector
- Knowledge of FAT, SAT, IQ, OQ, PQ procedures and documentation
- Knowledge of the Fill and Finish Line
- Integrity, strong ethics, analytical skills and attention to details
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.