Biopharmaceutical Process Engineer - Job Description:
Process Design Solutions is looking for an experienced process engineer who is self:motivated, outgoing, and articulate, to provide engineering support to our clients in a variety of capacities.
The candidate will serve as a consultant in a variety of process engineering roles, including development, design, and specification of biopharmaceutical equipment and processes. The successful candidate will be working hands:on with stainless steel and single:use bioreactors, ranging from 5L to 2000L; other equipment includes stainless steel and single:use UF/DF skids, chromatography skids, single:use centrifuges, harvest clarification POD and CUNO filter skids, CIP skids, roller bottles, and virus filtration skids.
Duties will also include management of small projects, ownership and implementation of change controls, and support of GMP deviations and investigations.
The candidate should have a working knowledge in any of the following disciplines:
Large:scale cell:culture and fermentation
Cell:separation and harvest
Process Support (media/buffer preparation, autoclaves, parts washers and COP washers
Change Controls and other quality systems
Experience with single:use systems is a plus
The candidate must be able to work independently, with minimal oversight, but also have the ability to work closely with others in a group setting. They must be comfortable speaking in public and interacting with the client daily, performing work at the client sites. A B.S. in engineering is required, with chemical engineering preferred. 2:5 years experience in the biopharma, biotech, and/or medical device industries is required.
Process Design Solutions is a Boston area based company that provides state of the art, best in class, process engineering solutions to the biotech, pharmaceutical and medical device industries. By appropriately applying the concepts and principles that support Quality by Design, we guide our clients toward improving all aspects of their engineering function, strategically focusing design efforts on product quality and patient safety. We partner with our clients as a trusted advisor to provide the highest possible value.
Specialties : Process Engineering, Single:Use Technology, Process Optimization, Quality Risk Management (QRM), ASTM E2500 Plan and Implementation
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