Process Consultant

2 weeks ago

Melbourne, Australia Pharmeng Technology Inc Full time

Advantage cGMP knowledge advance.
- Responsible for writing, executing, and summarizing efforts to develop equipment process parameters per the site SOPs, user requirements, and product needs.
- Participate in start-up of new facility, equipment, and processes in manufacturing.
- Knowledge of Chromatography and Tangential Flow Filtration a plus but not mandatory
- Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc.)
- Coordinates activities necessary to execute engineering study (lab support, commodities, etc.).
- Assists in documenting changes/updates to manufacturing processes and working with manufacturing, engineering, and validation to implement those changes.
- Assures professional and quality performance in all activities, meeting times, and cost and cGMP requirements.
- Adaptive and flexible to scheduling of engineering runs.
- Coordinate activities with the automation team to resolve automation issues and changes.
- Coordinate activities with maintenance to resolve mechanical issues.
- Additional activities related to equipment Engineering Studies as determined by the team lead.

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