Process Engineer – Illinois
Perform regular department inspections per SOP-GEN-31 to ensure facility is in good repair. Ensure facilities and equipment are in compliance to meet CFR / cGMP requirements. Become department equipment technical expert and facilitate equipment change control processes. Integrate within the Engineering Department organization and take on additional responsibilities when asked. Understand equipment capacities and limitations.
- Provide engineering support to manufacturing areas, including: process optimization studies, equipment research and commissioning, and technical expertise.
- Provide analysis and expertise using fundamental engineering principals to support completion/closure of Corrective Action Requests, Out-of-Tolerance Reports, and Change Controls.
- Provide data to support groups including: Quality operations, R&D, Regulatory Affairs, Microbiology and Validation.
- Support projects through data gathering, electronically or manually extraction from procedures/records, and by participating on project teams as a Manufacturing representative.
- Serve as department MES subject matter expert and liaison with facility infrastructure representatives.
- Bachelor’s degree-preferably in an engineering field.
- 1-2 years of engineering experience within a manufacturing field.
- Prefer strong academic analytical/statistical mathematical background.
- Thorough knowledge of fundamental engineering principles and applications.
- Solid understanding of cGMP guidelines.
- Excellent computer skills including LIMS and Microsoft Access, Excel and Word with specific strength in graphing functions.
- Effective communication and team-building skills necessary to successfully participate on teams.
This global organization is one of the world’s leading pharmaceutical companies with a comprehensive line of therapies dedicated to the treatment of hemophilia, immune, wound-healing, and other coagulation disorders. They have experienced phenomenal growth over the past 2 years and in the midst of a 5 year expansion, offering excellent opportunities for professional development and growth