Engineer II

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry.

Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL.

Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.  Position Summary cGMP Consulting is seeking a motivated and detail-oriented individual to lead projects, including engineering activities for equipment, utilities, facilities, systems, and processes.

This mid-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment.  The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and protocol completion while demonstrating independence.

This candidate should have a strong understand of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.  Responsibilities  The essential functions include, but are not limited to the following :

• Author specifications and supporting documentation (URS, RA, FS) for new processes, equipment, and / or systems.  Perform activities related to scoping, executing, and managing engineering projects involving facility modifications equipment upgrades, or process improvements.  Lead equipment commissioning testing in collaboration with Engineering for new equipment.  Conduct validation / qualification studies for utility systems, equipment, cleaning, processes, computer systems, and new products.
• This includes protocol preparation, execution, and final report documentation.
• Manage multiple qualification activities while providing deliverable updates and modifications to existing scheduling to support execution activities.  Lead cross-functional team meetings, including preparing agendas and documenting meeting notes.
• Facilitate follow-up meetings in regard to action items previously identified.  Assist in project forecasting and effectively plan requirements for upcoming tasks.  Program and operate analytical instruments (e.g., temperature / humidity dataloggers) for controlled temperature / humidity chamber qualifications, such as lyophilizers, warehouses, sterilizers, and incubators.  Collaborate with process experts and production personnel to identify and resolve technical challenges.  Provide technical expertise and recommend process improvements.  Draft change controls and deviations to address failures during qualification activities.
• Author SOP updates related to CAPA implementation.   Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols.  Utilize Word, Excel, Document Management Systems, and other electronic tools to complete tasks efficiently.  Perform additional tasks or duties as assigned by management.  Requirements  Bachelors’ degree in Engineering, Science, or a related field of study.  2-4 years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and / or reports.

Must be familiar with regulatory (FDA) requirements.  Expertise in one or more of the following areas :