Manufacturing Process Engineer - Katalyst Healthcares & Life Sciences

• Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.

• Gather and analyze process data using statistical process control methodology.

• Develop action plans to increase process robustness, prevent product loss, and control quality impact.

• Participate in process performance monitoring such as Track & Trend.

• Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.

• Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process.

• Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.

• Part of cross-functional team responsible for implementation of site projects/initiatives (continuous improvement, cost reduction, capacity increase, etc.) that lead to process remediation.

• Project management of smaller team, short duration projects within larger projects.

• Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.

• Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process/technology.

• Generate technical justification determining the impact of change and protocols/reports/manufacturing documents that support its execution.

• Assist the execution of experimental, demonstration, and validation lots.

• Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations.

• Writes justification memos and scientific reports of quality controls and manufacturing documents.

• Provide scientific and technical support during regulatory audits and agency inspections.

• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support Of's EHS program.

Requirements:

• BS or MS in Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical)

• 5-7 Years of experience

• technical experience in Process/Manufacturing/Project Engineering or similar role.

• years of experience in a similar role can be considered.

• Technical knowledge in fundamentals of biologics and/or antibody drug conjugation manufacturing.

• Effective verbal and written communication skills in English.

• Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.

• Gather and analyze process data using statistical process control methodology.

• Develop action plans to increase process robustness, prevent product loss, and control quality impact.

• Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process.

• Generate technical justification to support and/or document process changes.

• Support the execution of experimental, engineering, or process validation runs by providing technical assistance on the shop floor.

• Maintain up-to-date process documentation (manufacturing directions, batch records, standard operating procedures) and ensure they are in compliance.

• Generate and review reports to provide required information to regulatory agencies such as Annual Product Review.

• Strong knowledge of biologics and/or antibody drug conjugation manufacturing

• Structure problem solving, continuous improvement principle, project coordination

• Technical writing skills