Engineer

2 months ago

Waltham, United States Synectics Inc Full time
Job DescriptionJob Description

Responsibilities:

  • 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 plan 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 impact of change and protocols/reports/manufacturing documents that support its execution.

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

  • 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 EHS program.

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

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

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

Qualifications:

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

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

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

  • Effective verbal and written communication skills in English.

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

  • Structure problem solving, continuous improvement principle, project coordination

  • Technical writing skills

  • Experience Level = 5-7 Years

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