Engineer II

cGMP Consulting Inc.; Illinois; On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting Inc. in Illinois is seeking a motivated individual for a mid-level role to lead projects in a GMP-compliant environment. This position requires a Bachelor's degree and 2-5 years of GMP manufacturing experience.

Key responsibilities include managing engineering projects and conducting validation studies while ensuring compliance with FDA regulations. Expected annual compensation ranges between $75,000 and $95,000, along with a comprehensive benefits package.

Qualifications

• 2-5 years’ experience in a GMP manufacturing environment.
• Familiar with regulatory (FDA) requirements.
• Hands-on experience with temperature validation equipment.

Responsibilities

• Author specifications and documentation for new processes.
• Manage engineering projects involving facility modifications.
• Lead equipment commissioning testing and validation studies.
• Assist in project forecasting and requirement planning.

Skills

Cross-functional collaboration

Troubleshooting

Change management

Technical writing

Organizational skills

Communication skills

Interpersonal skills

Education

Bachelor’s degree in Engineering, Science, or a related field

Tools

Temperature validation equipment (e.g., Temptales, Kaye)

Word

Excel

Document Management Systems

Job description

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 understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

This position is open year round.

Responsibilities

• 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

• Bachelor’s 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: $75,000‑$95,000 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.