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Process Engineer II (Engineering)

Location: Framingham, Massachusetts
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The Engineer II is a technical role who is a member of the Project Engineering team and is accountable for the design, support and troubleshooting of upstream and downstream bioprocessing equipment. The Engineer II is expected to have the technical expertise to support Bioprocess Development and manufacturing systems. The person in this role is expected to have a good working knowledge of cGMP requirements and the ability to apply this knowledge to create engineering solutions with regards to the bioprocessing equipment.

Core Responsibilities
Function as a technical specialist on process equipment or systems; troubleshooting of equipment, update engineering documentation, and describe technical problems to other SMEs.
Execute concurrent projects with some supervision.
Interpret and execute policies and procedures.
Execute tasks, under the minimal direction of technical supervisors, to complete the project within schedule.
Utilize quality systems to ensure compliance with regulatory requirements.
Provide support for documentation changes
Develop and manage change controls
Comply with requirements from Sanofi Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements.

Bachelor’s degree in Engineering with 4+ years relevant industry experience.

Direct experience in a GMP environment.
Working knowledge of pharmaceutical/biotech processes.
Direct experience in the Biopharmaceutical industry designing, supporting, and troubleshooting Upstream and Downstream process equipment.
General understanding and wide application of technical principle, theories, and concepts in the Biotech/Pharmaceutical field.
General knowledge of other related disciplines(i.e. Automation , I&C).
Demonstrated skills in the following areas:
Problem solving and applied engineering
Basic technical report writing
Working knowledge of specialized equipment/processes.
General knowledge of Commissioning and Qualification.
Effectively interact with a variety of communication and working styles.

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