Process Development Engineer – Pharma/Medical Device
My client is a rapidly growing producer of medical-grade pharmaceutical ingredients and pharmaceutical processing equipment including ultrafiltration units and bioreactors, some of which are used by COVID-19 vaccine producers. This person will be attached to the R&D Engineering group with their main role being to develop, design, and test ultrafiltration units, typically in pilot-scale setting. These units are typically skid-mounted for internal production of reagents and once proven out, ultimately for commercial use. Responsibilities include testing these new processes, equipment documentation, analyzing lab data, working with outside vendors to fabricate production units, doing design-of-experiments (DOE), and conducting risk assessment analysis. This person will be attached to a large development engineering group who work in developing other medical devices and process. Growth potential includes moving into any of the multiple business units on site.
- B.S. Chemical/Mechanical/Bioprocessing Engineering
- Chemistry is a possibility
- 5+ years’ experience as a research engineer, development engineer, or a pilot plant engineer
- Preferred industries include biopharmaceuticals, medical devices, active pharmaceutical ingredients (APIs), polymers, plastics, resins, or chemicals
- Some statistical development, DOE, GC, or process validation experience is required
- Huge plus would be experience with liquid processing with any type of filtration like ultra-filtration or reverse osmosis.
- Other pluses would be experience with extrusion, fiber processing, instrumentation, equipment vendor relationship building, and GMP
- FMEA experience HIGHLY preferred, not a must-have
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