You will serve as technical support for commercial manufacturing and new product introduction in a state of the art facility.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving investigations.
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
- Statistical data analysis to support development and commercialisation batches.
- Leading and active participation in projects, system failure investigations and investigation reports,
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
You should have an Engineering degree with at least 2 years experience working in the pharmaceutical or biopharmaceutical industry.
Experience working in a biopharmaceutical start-up facility would be particularly beneficial
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