Engineer Process Support

Spectraforce Technologies; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies in North Chicago, IL is seeking an Engineer Process Support for a 12-month hybrid assignment. You will lead manufacturing process projects to improve yield, quality, cycle time, and cost, and apply statistical process control to monitor performance and drive action plans.

You will provide technical shop-floor support, investigate root causes, document deviations, and collaborate with cross-functional teams on site initiatives while ensuring compliance with procedures

Qualifications

• BS/MS/PhD in Chemistry or Engineering or related field.
• 7+ years in Process/Manufacturing/Project Engineering.
• Fundamentals of pharmaceutical process knowledge.
• Effective English verbal and written communication.

Responsibilities

• Lead projects to improve yield, quality, cycle time and cost.
• Gather/analyze process data via statistical process control.
• Provide technical shop-floor support for operational issues.
• Lead root-cause investigations and document recommendations.
• Collaborate in cross-functional site initiatives (CI, cost reduction).
• Project management of smaller teams within larger projects.
• Support process validation for changes/new materials/tech.
• Maintain process docs and support regulatory audits.
• Demonstrate EHS accountability and program participation.

Skills

Process engineering

Manufacturing engineering

Project management

English communication

Education

Chemistry or Engineering degree

Job description

Job Title: Engineer Process Support
Duration: 12 Months
Location: North Chicago, IL 60064 (Hybrid)

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 EHS program.

Qualifications

• BS or 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).
• Effective verbal and written communication skills in both English.

Key Stakeholders

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

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