Production Engineer - Devens MA

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Summary: Reporting to the Director of Downstream Operations, Production Engineer/Scientist 1 of the Single Use Facility is responsible for advancing the biologics pipeline according to established work instructions and in accordance with current Good Manufacturing Practices (cGMPs).  The role is based in a state of the art facility utilizing single-use technology.

 

The Production Engineer/Scientist 1 is responsible for mastering all routine manufacturing assignments/processes, providing daily technical oversight of execution of manufacturing processes, provide in depth training, maintaining a culture of compliance, and innovation within the downstream team.  The Production Engineer/Scientist 1 is required to guide the shift personnel with technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.

 

 

Responsibilities

o    Master and work on routine manufacturing assignments as well as assignments that are complex in nature where action and a high degree of initiative are required in resolving problems and making recommendations.

o    Provide in depth training.

o    In adherence to Good Manufacturing Practices and standard operating procedures effectively use and possesses mastery of various production equipment, process automation, and supporting business systems to support biologics production within the downstream operations.

o    Ensure less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and work instructions and work with individual team members to ensure training is completed on time.

o    Under direction of area management, lead the coordination and implementation of special projects such as validation or support routine process investigations. 

o    Revise and create process documents.

o    Champion areas specific initiatives associated with work safety and operational improvements.

o    Engage in and support culture of continuous improvement through ownership of improvement for work processes, equipment and safe work environment.  Advise Shift manager on improvements which may optimize work processes.