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. 

Job Summary 

This position is responsible for providing technical support to the Engineering teams for managing vendors, commissioning testing, and design review. The individual must have the ability to write reports clearly, concisely and accurately.  A basic understanding of current Good Manufacturing Practices (cGMP) is also required to perform these duties. Knowledge of controls is a plus. 

Responsibilities 

• Performs specification, procurement, commissioning, and operation of API processing equipment (reactors, mix tanks, centrifuges, various types of filters, dryers, and drum filling equipment). 

• Performs commissioning studies (utility, equipment, cleaning, process computer, and new products) which can also include writing Risk Assessments, protocol preparation, scheduling, protocol execution, and final report preparation.

• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.). 

• Represents Technical Services in teams assembled to specify, install, troubleshoot and maintain systems, equipment and processes. 

• Responsible for managing multiple deviation investigations simultaneously. 

• Provides follow up and scheduling to qualification process is not impacted by outstanding deviations. 

• Works with process experts and production personnel to fully understand and solve problems, 

• Provides technical expertise and recommends improvements. 

• Utilizes Word, Excel, Documentum and other electronic systems to complete tasks. 

• Maintains compliance with company policies, training requirements, cGMPs and safety standards. 

• Perform any other tasks/duties as assigned by Management. 

Requirements 

• Minimum 4-year degree in a Science or Engineering field of study 
• 1-3 years' of applicable cGMP manufacturing experience, writing standard operating procedures and protocols and/or reports. Familiar with regulatory (FDA) requirements.
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.

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.