Engineer

Hello This is Komal from Intellectt we have an opening for a Engineer in Waltham, MA. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at 1(732)-813-9025.

Job Title: Engineer

Location: Waltham, MA 02451

Duration: 4 Months

Responsibilities

Job Description:

• 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