Commissioning and Start-Up Engineer (Filling Line Expert) (VT-22)Location: Melbourne, AustraliaSector: EngineeringPerform commissioning and troubleshooting/process activities on filling linesPharmaceutical manufacturing project located in the Northern Suburbs6 - 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.We are seeking a Filling 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 lineSet-up and tuning of machine parametersVHP cycle developmentManagement of qualification and test plans according to specific technical requirements, requirements-testing traceability matrixes, and design qualification and summary reportsDrafting, verification, and execution of protocols and qualification tests (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 instructionsStandardization of operating proceduresCalibration of devices (automatic and manual)About you:Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)Minimum of 5 years of experience in Pharmaceutical SectorKnowledge of FAT, SAT, IQ, OQ, PQ procedures and documentationKnowledge of the Fill and Finish LineIntegrity, strong ethics, analytical skills, and attention to detailTo submit your application in strict confidence, click the 'apply' button.
If you require further information, please contact Voula Triantafillou on 0437 853 201.
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