Process Engineer

Title: Process Engineer / Manufacturing Process Engineer

Location: North Chicago, IL 60064

Onsite

7+ year's Experience

Some Travel is involved in this role (Some trips to New York) (Need to travel onsite during engineering runs) (10% travel needed with in US or outside US)

• There is not too much design control work involved in this role
• Gap assessment
• Medical Device or Food industry experience will also work
• technical Transfer exp needed (Must have)
• PM skills
• Process development exp (must have)
• Exp in pharma
• Work is technical transfer of products
• Sterile Mfg. knowledge is a plus
• Mfg. site supporting sterile pharma product is a plus
• Exp working in cross functional team
• Pharma background and GMP exp (Must have)
• Attending meeting throughout the week (project team meetings)
• Write protocols, engineering runs, PPQ
• PM exp working in cross functional teams would be beneficial

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 Client's EHS program.

Qualifications:

• BS or MS in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical)
• 5-7 years' of technical experience in Process/Manufacturing/Project Engineering or similar role.
• Technical knowledge in fundamentals of pharmaceutical liquid-solid dosage forms processing.
• Effective verbal and written communication skills in English.

Key Stakeholders:

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

The profile for the Ideal candidate would be someone who gets a tick mark on all of these:

• Sterile product support, aseptic process development (with hands on experience)
• Experience with process validation and technology transfers
• Experience with design control

What are the top 3-5 skills requirements should this person have?

• 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 both English.
• Strong data analysis skills and experience (will be doing a lot of data mining)

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Sterile GMP, Project Management, IND and BLA submission, Six Sigma.
• Eyecare product ophthalmic experience with mfg or development