Process Engineer at Wall Street Consulting Services LLC Process Engineer at Wall Street Consulting Services LLC in Lake Bluff, Illinois Posted in 1 minute ago.

Type:

full-time

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