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Principle Process Engineer Plasma Fractionation

2 weeks ago

Sydney, New South Wales, Australia Aegros Full time $120,000 - $180,000 per year

Company Description

At Aegros, we believe that access to life-saving therapeutic plasma drugs is a human right, not a privilege. Our mission is to prioritize patients through innovation, using our Australian-invented Haemafrac, a unique electroseparation process. Our TGA GMP-approved plasma fractionation plant in Macquarie Park, Sydney, manufactures a hyperimmune immunoglobulin product against Covid-19. Aegros is currently preparing to register this product on the Australian Register of Therapeutic Goods (ARTG) while upgrading its current facility to process 100,000 liters of plasma per year.

Role Description

This is a full-time, on-site role located in Sydney, NSW, for a Principle Process Engineer specializing in Plasma Fractionation. The Principle Process Engineer will be responsible for designing and implementing efficient process engineering solutions, overseeing process control systems, analyzing and optimizing chemical processes, and ensuring regulatory compliance. Day-to-day tasks will include process design, control, and troubleshooting to enhance production capabilities and maintain high standards of product quality and safety.

We are seeking a Lead Process engineer to join our Global Engineering Team to assist in the design development of Aegros upstream and downstream process and equipment design. This person will work with the Global Engineering Leadership team to develop Global Process Engineering standards, URS Templates, engineering specifications, refine mass balances and either lead an in-house process design team or supervise a third party in the basic, detailed and construction issue of drawings. 

They will be responsible for the design definition and CQV approach for Aegros manufacturing process. They will develop and approve P&IDs, PFDs, and optimize simulation software for the various production outputs required for Aegros Modular plant design. They will have experience in BioProcess DSP and purification with specific experience in Tangential Flow, Ultra and Diafiltration, single-use equipment, including mixers for bags, depth filtration and preferably handling and purification of blood plasma. They will perform a range of tasks including:

· Commissioning and qualification of Process Equipment, clean and black utility equipment, including attendance at FAT/SATs

· Develop Heat and Mass Balances, using computer simulation tools (Previous experience of SchedulePro is an advantage)

· Vendor evaluation and selection, including performing commercial bid analysis

· Developing Process Flow Diagrams (PFD's), process and instrumentation diagrams (P&ID's), data sheets, and develop/edit purchase specifications for associated Process and/or utility equipment

· Developing calculations for utility loads and equipment sizing, etc

· Attendance at HAZOP studies as either SME or system owner

· Component and system risk assessments

· Developing Alarm and trip schedules and ESD philosophy

· Line sizing and relief venting calculations, inclusive of development of Pressure relieving philosophy and 2 Phase flow relief

· Performing P&ID walkdowns and markups as required for punch-lists or As Build's

· Ability to manage both internal and external budget and schedule constraints.

To be the successful applicant for this great opportunity, you should ideally possess:

· Minimum Bachelor Degree in Chemical, Biotechnology or Biochemical Engineering

· years of process experience in pharmaceutical/bio-pharmaceutical and cGMP environments. Biological/blood processing/sterile injectable experience is an advantage.

· Subject matter expert in at least one of the following areas : Upstream/Downstream Biotech Equipment, Aseptic Fill / Finish

· Good Knowledge of EU / PICS / FDA GMP

· Good understanding of automation experience (DCS / Delta V)

· Process simulation and modelling experience (preferably on SuperPro/SchedulePro)

  • Proficiency in MS Office applications and good working knowledge of bioprocessing software such as AutoCAD, scheduling software and SchedulePro

· Excellent communication skills in English, verbally and written skills

·
Highly motivated and a pro-active self-starter.

· Willingness to travel up to 50% of the time

If you have the skills and experience to successfully carry out the requirement of the role, we would like to hear from you Please click Apply and include your CV.

Note to agencies: This recruitment exercise is being managed directly by Aegros. We will reach out to our preferred agency partners, if required. Your respect for this process is appreciated.