Principal Pharmaceutical Process Engineer

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Irfa******

  • Australia 
  • Last Update: 08.04.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
7 Month +
Place
Sydney, AU
Country
Australia

Category


General Administrative

Description


Responsibilities You will Partner with R&D, Manufacturing and Quality teams, your responsibilities will include yet not be limited to Whilst you will be contributing to and defining the release strategy of this game changing product, you will also be the subject matter expert in the technical manufacturing process of this innovative new product.
  • Lead and define the strategy for product set up and process validation for new product introductions and process changes.
  • Lead experimental planning for manufacturing process characterisation, and defines critical process parameters for chemical manufacturing processes.
  • Leads supplier audit and ensures protocol execution is per plan, while establishing methods for ongoing monitoring/trending of product.
  • Lead reviews and approval of site documents to include calibration reports, batch records, SOP’s, change control, and design specifications for production chemicals.
Essential Experience
  • Pharmaceutical development, pilot scale production.
  • API/Excipient Formulation/ Mixing Development (Characterisation, Validation) for Drug Eluting Medical Devices.
  • Micronised powder handling, facility design and WHS experience.
  • Experience with potent Schedule 4 API’s.
  • Cleaning validation, including manual processes.
  • Process monitoring – Specification setting, Control Plan definition, Batch size determination.
  • Retention sample creation and storage.
  • Stability Program setup and maintenance, shelf-life determination.
  • Formulated intermediate shelf-life studies.
  • Regulatory Requirements for Medicinal Products, cGMP requirements.
Ideal
  • Combination Devices, Implantable Medical Devices.
  • Mixing highly viscous materials with powders.
  • Control of containers/ closure systems.
  • Familiarity with analytical chemistry test methods.
  • Equipment selection
  • UV sensitive processing.
  • Knowledge of supply-chain controls.
  • Ethylene Oxide sterilisation validation experience.

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