MIT Engineer

cGMP Consulting•Melrose Park, IL

55d•$85,000 - $100,000

About The Position

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.

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.

Responsibilities

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.