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.
• 2-5 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: cleaning validation qualification of aseptic filling or formulation equipment/processes qualification of component preparation equipment/processes and packaging.
• Hands-on experience with temperature validation equipment (e.g. Temptales Kaye etc.).
• Advanced critical thinking and technical writing skills.
• Strong organizational communication and interpersonal skills.

Compensation and Benefits

• Expected pay range per year: $75000-$95000 USD
• Expected benefits include: Medical Dental Vision PTO 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge skills or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer drug-free workplace and complies with ADA regulations as applicable.