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Client Services Director | International Projects | Project Management & Engineering at Blackfield Associates
Blackfield Associates are currently supporting a global biotechnology company in the search for a Filling Line Engineer for a large CAPEX expansion project in the Melbourne area.
This position would best suit a candidate from either a Process Engineering or Project Management background, who has experience working with Aseptic Filling Lines throughout full project phases.
Overview:
* Commissioning and troubleshooting during Startup + Debug phase of the filling line
* Set-up and tuning of machine parameters
* 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 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 recognized guidelines (e.g.: ISPE, GAMP)
* Development of project validation master plans for new site 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
This position is open to both contract and permanent hires.
Please apply for a confidential discussion.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function:
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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