MIT Engineer

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 an experienced and driven individual that supports, maintains, and enhances the digital systems that enable compliant, reliable, and efficient pharmaceutical manufacturing operations. This role works closely with manufacturing, quality, automation/OT, and corporate IT teams to ensure GMP‑critical systems remain secure, validated, and fully integrated with plant operations. The ideal candidate has experience in a pharmaceutical or regulated manufacturing environment and understands both IT fundamentals and manufacturing process requirements.

Responsibilities

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

• Provide day‑to‑day support for manufacturing IT systems, including MES, LIMS, historian databases, electronic batch records, and site‑level applications.
• Troubleshoot system issues, perform root‑cause analysis, and implement corrective actions with minimal downtime.
• Monitor system performance and proactively identify improvements or necessary maintenance activities.
• Collaborate with automation/OT teams to ensure reliable communication between IT systems and floor equipment (PLCs, SCADA, DCS, data historians).
• Support data flows between MES, ERP, QMS, and other enterprise systems.
• Assist with networking, including switches, servers, VLANs, cybersecurity controls, and segmented GMP networks.
• Ensure all systems operate in compliance with FDA, EMA, GxP, and data‑integrity requirements.
• Participate in validation activities for new systems, upgrades, patches, and infrastructure changes (e.g., IQ/OQ/PQ documentation).
• Maintain accurate system documentation, SOPs, and change‑control records.
• Assist in implementing new applications, dashboards, and data‑analytics tools that improve manufacturing efficiency and data visibility.
• Collaborate with cross‑functional teams to streamline workflows and integrate new technologies.
• Implement and maintain IT security controls, user access reviews, patching schedules, and network protection for GMP systems.
• Ensure alignment with corporate IT policies, disaster‑recovery requirements, and backup/restore procedures.

Requirements

• Minimum Bachelors’ degree in Engineering, Science, or a related field of study.
• 3+ years of experience in pharmaceutical, biotech, or other regulated manufacturing environments.
• Understanding of GxP, data integrity principles, and system validation.
• Experience supporting manufacturing systems such as MES, LIMS, historians, or similar platforms.
• Familiarity with IT/OT‑level networking, servers, databases, and cybersecurity concepts.
• Strong troubleshooting, communication, and documentation skills.

Compensation and Benefits

• Expected pay range per year: $85,000-$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.