Manufacturing Science and Technology (MSAT) is responsible for process development and improvement of both new and existing products. It is also responsible for the transfer of technology from a laboratory environment to full scale commercial manufacturing. In additions it provides support for validation, trouble-shooting and investigations. MSAT strives to attain a high level of technical expertise and knowledge of the processes we support as well as an understanding of compliance requirements and cGMP considerations required by our operations.
We are looking for a candidate at the level of Process Engineer II to help drive process development activities and to support improvements to current commercial products as well as operate under the regulatory requirements for drug and medical device manufacturing.
Provide technical support and guidance for the design, development, scale-up and transfer of processes for the production of new or existing products.
Design and conduct necessary experiments to achieve desired goals and to solve problems in creative and practical ways.
Analyze and interpret experimental data; recommend changes or additional experiments, prepare technical reports, SOPs, and presentations.
Work independently with minimal supervision and direction; maintain and demonstrate knowledge of state-of-the-art principles and theories in the area of responsibility.
Provides technical guidance and trains less experienced technicians.
BS in chemical or biochemical engineering, or related degree supplemented with relevant experience. Experience in pharmaceutical/biopharmaceutical industry or related industry/cGMP environment. Based on level, should have demonstrated experience with manufacturing processes and equipment such as CIP systems, filtration skids, sterilization, aseptic processing and pharmaceutical manufacturing equipment, etc. Experience with scientists / Manufacturing Technology in technology transfer from bench scale to full scale manufacturing. MS in engineering preferred. Well-developed communication skills, both verbal and written
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