The Manufacturing Technology Associate Engineer will champion process equipment within Manufacturing Operations (upstream and downstream processing, the cryogenics facility, as well as materials management) and will implement process improvements through equipment projects, equipment-related investigations and process equipment strategies to support robustness in manufacturing. The position reports to the MT - Engineering Manager, Manufacturing Technology - Syracuse.
Champion process equipment and process equipment improvements and implement equipment robustness within manufacturing.
Lead Quality Investigations to determine root causes for process equipment deviations.
Author, champion, and drive implementation of change controls for process equipment.
Analyze the impact of equipment on process performance, collect and analyze data to identify improvements, and devise then implement robust solutions.
Author protocols and final technical reports for process equipment studies. Review cGMP documentation as required.
Perform cleaning and mixing validation studies for the Syracuse site. Author and execute protocols and reports and monitor study execution in manufacturing.
Collaborate closely with the process experts in Manufacturing Science & Technology and interface with scheduling, quality assurance, facilities and other Manufacturing and engineering functions.
Participate in network-wide alignment and optimization of Manufacturing Technology business processes and equipment strategies and use expertise to assist in process technical transfer.
Specific Knowledge, Skills, Abilities, etc.:
Experience should include technical support of a cGMP Biologics manufacturing facility, including knowledge of drug substance processing equipment.
Technical writing and data presentation abilities are required.
Demonstrated problem solving ability, in-depth experience with manufacturing systems and equipment, good interpersonal, oral and written communication skills are essential. Operational Excellence experience and project management skills are desired.
Experience with regulatory agency inspections, regulatory responses and Quality Risk Management is a plus.
This position is primarily an office-based role and requires repetitive use of hands and wrist (computer work) and infrequent lifting of items not to exceed 50 lbs. Occasional bending, twisting, and stooping to allow for gowning into classified environment required.
This position is primarily office based with occasional work in a classified GMP manufacturing environment. Work will take part both individually and as part of a group.
The position may manage contingent workers and is responsible for supporting the safety culture of the group and site.
Bristol Myers Squibb