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Maintenance Project Engineer / Australia

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Location: Melbourne, Australia
This is an excellent opportunity for an Maintenance and Reliability Project Engineer to join a leading manufacturing business, working on a highly interesting project. The position will be based in the Northern part of the Melbourne CBD, and is a 12 month contract. 
Job Description:
Key contributor and technical support in team activities associated with maintenance, continuous improvement and capital projects related to the operation and maintenance of the Clinical Manufacturing Facility. This position may involve some indirect supervision of personnel and contractors who provide support and services to the facility.

• Assist in management of equipment and services-related continuous improvements, capital projects and change controls
• Assist in plant shutdowns, start-ups and maintenance interventions
• Assist in the response and close-out of utility and equipment-related non-conformance & deviations
• Review and generation of technical diagrams for processes within the Clinical Manufacturing Facility
• Review and maintenance of all CMF equipment as listed in the asset management system
• Review of inventory management and documentation within the CMF
• Effectively represent Pilot Scale Operations in project meetings
• Respond to in-hours and out-of-hours alarm calls
• Communicate ideas and results succinctly in both written and oral presentations
• Be flexible and adaptable to changing work place priorities
• To support the successful completion (as measured by product yield, quality & consistency and the achievement of project timelines) of GMP manufacturing campaigns
• To support the operational support team, including occasionally assisting other team member (e.g. assisting in validation activities or cleaning scheduling)
• Ensure high safety standards within the areas of responsibility are taken into account and adhered to as governed by local, state and federal regulations, laws and policies as well as the company’s policies and directives.
Experience and Qualifications:
  • B.E in Chemical/Mechanical or higher degree
  • 2+ years’ experience in pharmaceutical or manufacturing sector
  • GMP Experience
  • Knowledge of complex engineering services and systems (e.g. WFI, PFS, HVAC)
  • Proficient with computerised process control systems (SCADA)
  • Developed experience with clean room facilities and practises
  • Strong writing skills as related to data compilation, document creation and report writing
  • Ability to read Engineering Drawings and Schematics
  • Knowledge on process flow diagrams and a basic understanding of piping and instrumentation diagrams (highly preferred)

Nice to haves:
  • Understanding of pilot scale operations and facility design
  • Understanding of cell culture, purification and formulation processes and familiar with the processing operations and associated equipment
  • Awareness of various regulatory guidance’s such as PIC/s, FDA, EMEA, ICH and TGA
  • Excellent data analysis, trending and reporting/presentation skills
Additional Information:
  • Some working hour flexibility with a requirement for periods of overtime/weekend work
  • Must be double vaccinated for Covid 19
Benefits of this role;

  • Work with a world class business on high profile projects.
  • Work within a highly skilled team.
  • Excellent remuneration.

How to Apply

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