cGMP Consulting Inc. ยท 1 month ago
MES Engineer
North Chicago, IL
Full-time
Onsite
Mid Level
$80K/yr - $115K/yr
3+ years expcGMP Consulting Inc. specializes in providing expert validation, qualification, and compliance services to the life sciences industry. They are seeking an experienced MES Engineer to support manufacturing production activities and improve efficiency and compliance in GMP-regulated environments.
Pharmaceutical
Responsibilities
Design, configure and implement MES solutions specifically for GMP-regulated pharmaceutical manufacturing environments
Translate batch records, SOPs and process requirements into electronic workflows and MES functionalities
Support design and configuration of modules such as eBR (Electronic Batch Records), Weigh & Dispense, Equipment Logbooks, and Recipe Management
Integrate MES with ERP (e.g., SAP), LIMS, historians, QMS, SCADA/PLC systems, lab equipment, and automated manufacturing equipment
Collaborate with automation, IT and quality teams to ensure reliable and validated system integrations
Provide GMP-compliant support for MES applications, resolving deviations, incidents, and change requests
Maintain system availability, conduct periodic reviews, and ensure adherence to validated system states
Manage MES updates, patches and change controls following pharmaceutical quality procedures
Optimize electronic batch record execution, reducing manual effort and ensuring error-free data capture
Support manufacturing operations during batch execution, investigations, and batch release activities
Support or lead MES implementation and enhancement projects across pharmaceutical production lines (e.g., solid dose, biotech, aseptic, packaging)
Coordinate with Manufacturing, Quality, IT and Engineering teams to meet project deliverables and timelines
Perform system testing, validation, and user acceptance testing (UAT) in accordance with GMP validation practices
Comply with company policies and procedures, Engineering Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements
Qualification
Required
Bachelors' degree or equivalent required, preferably in an engineering or related field
3-5+ years of experience in manufacturing / production processes with good writing skills
Experience with POMS and SAP
High computer and MS Office skills, Python, SQL, Power Apps, Power BI, and Power Automate
Working knowledge of safety, quality systems, and current Good Manufacturing Practice as applied to equipment and process steps in area of responsibility is required
Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner
Effectively work in a team environment
Maintain high level of energy and professionalism on the job
Build effective working relationships with customers, co-workers, cross-functioned groups, and management
Benefits
Medical
Dental
Vision
PTO
401K
Company
cGMP Consulting Inc.
Founded in 2001, cGMP Consulting Inc.
51-200 employees
H1B Sponsorship
cGMP Consulting Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (2)
2023 (2)
2022 (3)
Funding
Current Stage
Growth StageLeadership Team
Kevin Linde
CEO cGMP Consulting Inc.
Kate Aschoff
Chief Operating Officer
Company data provided by crunchbase