MES 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 MES Engineer to support manufacturing production activities. They will support projects that improve manufacturing efficiency and safety decrease costs decrease opportunity for human error or increase compliance. This individual will use POMS SAP and other systems programs and databases to input verify monitor and analyze pertinent data. They will be able to identify opportunities for improvement of manufacturing and business processes. They will propose plan and facilitate the improvement solutions and are responsible for production metrics standards and reporting on a weekly basis.

This rolerequires excellent analytical abilities the ability to understand complex solutions and processes and a strong focus on driving data quality improvements. This candidate will work cross-functionally with local and global teams in a GMP-compliant manufacturing environment.

Responsibilities

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

• 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.

Requirements

• 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 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.

Compensation and Benefits

• Expected pay range per year: $80000-$115000 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.