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 Description

cGMP Consulting is seeking an experienced and driven individual to lead and manage multiple high-impact projects, including validation and qualification activities for HVAC, utilities, and facility systems and processes. This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment. 

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, address high priority requests, and effectively lead and manage multiple projects to completion. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment.

Responsibilities

The essential functions include, but are not limited to the following: 

• Lead the development and authorship of detailed specifications and supporting documentation (URS, RA, FS) for HVAC, utilities, and facility systems and processes, ensuring alignment with regulatory expectations and project goals.
• Oversee and drive engineering projects involving facility modifications or process improvements from concept through execution, providing technical direction and project leadership.
• Direct and coordinate equipment commissioning activities, working closely with cross-functional Engineering and Operations teams to ensure readiness for validation and production.
• Design, execute, and review complex validation/qualification studies for HVAC, utilities, and facility systems and processes. Ensure compliance through robust protocol development, execution oversight, and authorship of final reports.
• Manage multiple concurrent qualification initiatives, proactively adjusting timelines and deliverables while communicating with stakeholders to ensure project alignment and successful execution. 
• Facilitate and lead cross-functional team meetings, providing strategic input, developing meeting agendas, documenting critical decisions, and ensuring timely follow-up on action items. 
• Contribute to capital project forecasting and long-term resource planning, ensuring engineering activities are adequately staffed and supported. 
• Collaborate with subject matter experts and manufacturing personnel to troubleshoot complex technical issues and implement effective, compliant solutions. 
• Act as a technical authority by identifying and recommending process and equipment optimizations based on performance data and industry best practices. 
• Ensure adherence to all applicable company policies, training requirements, cGMP regulations, and safety standards, while serving as a mentor for junior team members on compliance best practices. 
• Support broader site and departmental initiatives through the performance of additional leadership tasks or assignments as designated by management. 

Position skills and requirements:

• Minimum 4-year degree in an Engineering field of study; or equivalent experience.
• 5+ years experience in a GMP manufacturing environment, HVAC systems, and writing standard operating procedures. Familiar with regulatory (FDA) requirements.
• Understanding of equipment validation requirements and process.
• Strong organization and computer skills.
• Highly motivated and independent individual.
• Detail oriented and comfortable working in a fast-paced office environment.
• Exceptional communication and leadership skills.
• Superior organizational, communication, and interpersonal skills are necessary.

Compensation and Benefits

• Expected pay range per year: $75,000-$100,000 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.