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Associate Process Engineer
Ref No.: 17-01556
Location: Devens, Massachusetts
Position Type:Contract
Start Date / End Date: 11/24/2017 to 05/23/2018
ASSOCIATE PROCESS ENGINEER
DEVENS, MA

Project Description:
Serves as a process technical lead and subject matter expert to small/large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals at Devens manufacturing.

The successful candidate will be key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical and Global Regulatory Sciences groups. Strong communication and technical writing skills are required. The incumbent will lead the design and execution of experiments for design & control of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations. Appropriate GLP/GMP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale and the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots.
  • Demonstrates breadth of knowledge in biology, biochemistry, cell culture development and operations with the ability to apply this knowledge to the design, implementation and interpretation of experiments.
  • Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation and preparation of regulatory filings.
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for Client Devens Cell Culture facilities.
  • Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process.

Required Skills:
  • B.S., in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
  • Experience in contributing to the design, modification and optimization of cell culture or fermentation unit operations.
  • Experience with bioprocessing, biological systems, assay development, and experiment design highly preferred.
  • Proactively identifies problems and troubleshoots solutions.
  • Organizes and presents data for internal/external scientific meetings.
  • Works independently, in teams and collaborates with other groups in a matrix environment.
  • Leverages emerging trends in biotechnology to solve complex problems.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Steven: steven@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01556
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE