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
