Pharmaceutical Process Scientist /Engineer (Sterile Product Manufacturing)

$124,800 - $128,960/Yr

Systems Ally - North Chicago, IL

Full-time - Mid Level

North Chicago, IL

About the position

The Pharmaceutical Process Scientist/Engineer role focuses on leading projects in sterile product manufacturing to enhance process efficiencies, improve quality, and reduce costs. The position requires technical expertise in process engineering and involves data analysis, project management, and compliance with regulatory standards.

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 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 causes and developing recommendations related to product and process.
• Generate technical justifications to support and document process deviations/investigations and determine impact on product quality, yield, and product registration.
• Be part of a cross-functional team responsible for implementing site projects/initiatives that lead to process remediation.
• Manage smaller team projects within larger projects, including 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 processes/technology.
• Generate technical justifications determining the impact of changes and protocols/reports/manufacturing documents that support execution.
• Assist in the execution of experimental, demonstration, and validation lots.
• Maintain up-to-date product process documentation and ensure 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 the EHS program.

Requirements

• BS or MS or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
• 5-7 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 English.

Nice-to-haves

• Experience in pharmaceutical process (sterile product manufacturing) preferred: 8 years.
• Experience as a Process/Manufacturing engineer preferred: 8 years.
• Experience in process validation preferred: 8 years.
• Experience in process documentation preferred: 8 years.
• Experience in documenting process deviations/investigations preferred: 8 years.

Benefits

• Flexible schedule
• Health insurance
• Life insurance
• Paid time off