Engineer Process Support III

JobDiva, Inc.; Waukegan (IL); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior process/manufacturing engineer to lead projects in pharmaceutical process areas, focusing on yield, quality, and cost reductions. You will gather and analyze data using SPC, develop action plans, and drive process robustness.

The role requires 7+ years of technical experience, and strong communication in English. You will work with Manufacturing, Quality, Supply Chain, and Engineering teams to implement site projects and ensure compliance with

Qualifications

• BS, MS, or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
• 7+ years of technical experience in Process/Manufacturing/Project Engineering or similar role.
• Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing), and site transfer.
• Effective verbal and written communication skills in English.

Responsibilities

• Lead projects in manufacturing process areas to achieve process efficiencies such as increased 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.
• Provide technical support in the resolution of shop floor situations and execute assigned tasks as required by the operational area.
• Lead investigations by following a structured 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 on product quality, yield, and product registration.
• Participate as part of a cross-functional team responsible for implementation of site projects/initiatives, including continuous improvement, cost reduction, capacity increase, etc., that lead to process remediation.
• Manage smaller team, short-duration projects within larger projects. Responsibilities 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. Write 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 client's EHS program.

Skills

Process engineering

Statistical process control

Root cause analysis

Project management

Cross-functional collaboration

Technical writing

English communication

Education

BS in Chemistry or Engineering

MS in Chemistry or Engineering

PhD in Chemistry or Engineering

Job description

Roles and Responsibilities:

• Lead projects in manufacturing process areas to achieve process efficiencies such as increased 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.
• Provide technical support in the resolution of shop floor situations and execute assigned tasks as required by the operational area.
• Lead investigations by following a structured 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 on product quality, yield, and product registration.
• Participate as part of a cross-functional team responsible for implementation of site projects/initiatives, including continuous improvement, cost reduction, capacity increase, etc., that lead to process remediation.
• Manage smaller team, short-duration projects within larger projects. Responsibilities 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. Write 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 client's EHS program.

Education and experience:

• BS, MS, or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
• 7+ years of technical experience in Process/Manufacturing/Project Engineering or similar role.
• Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing), and site transfer.
• Effective verbal and written communication skills in English.

Key Stakeholders:

• Manufacturing
• Quality
• Supply Chain
• Operational Excellence
• Engineering
• EHS