Manufacturing Engineer

1 week ago

waltham, United States Intellectt Inc Full time

Job Title: Engineer

Location: Waltham, MA 02451

Duration: 4 Months


Job 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.
  • 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.

Qualifications:

  • BS or MS in Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical) technical experience in Process/Manufacturing/Project Engineering or similar role. years of experience on 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.
  • Scope of Work:
  • 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 plan 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 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.

Capabilities:

  • 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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