Electronic Batch Record Engineer - Electronic Batch Record

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 a motivated and detail-oriented individual to manage electronic batch records through the PAS-X system, including template design, compliance oversight, and change control for manufacturing documentation. This mid-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment.

The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and EBR release activities while demonstrating independence. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines, including 21 CFR Part 11.

This is a Contract to Hire position located in Melrose Park, IL.

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

• Generate and design executable electronic batch records (EBRs) within PAS-X for shop floor manufacturing operations.
• Create, revise, and maintain Standard Operating Procedures (SOPs) related to batch record design and execution.
• Design and implement continuous improvement initiatives for batch manufacturing documentation and workflows.
• Integrate PAS-X with enterprise systems, including SAP and an EDMS/document management system, to support seamless data flow across manufacturing and quality systems.
• Automate the integration of manufacturing equipment data into PAS-X.
• Monitor PAS-X system performance using Key Performance Indicators (KPIs) and document findings.
• Partner with Manufacturing, Quality, and IT/Automation teams to test, troubleshoot, and validate EBR templates prior to release, including resolution of system deviations.
• Manage the EBR change control process, including impact assessments, revision tracking, and coordination of approvals across Manufacturing, Quality, and IT/Automation stakeholders.
• Support ISO 50001 energy management system maintenance; identify energy efficiency opportunities and analyze consumption data.
• Lead EBR-related cross-functional team meetings, including preparing agendas and documenting meeting notes. Facilitate follow-up meetings regarding previously identified action items.
• Draft and investigate change controls and deviations related to EBR configuration errors or execution failures.
• Provide technical expertise on PAS-X system capabilities and recommend process or workflow improvements.
• Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols.
• Utilize Word, Excel, Document Management Systems, and other electronic tools to complete tasks efficiently.
• Perform additional tasks or duties as assigned by management.

Requirements

• Bachelor's degree in Engineering, Information Technology, Computer Science, or a related field of study.
• Programming or configuration experience with workflow automation platforms (e.g., PAS-X) in a pharmaceutical setting.
• Manufacturing knowledge of aseptic and terminally sterilized parenteral drug products.
• Database and virtual machine experience.
• Working knowledge of 21 CFR Part 11 and data integrity requirements as applied to electronic records and electronic signatures.
• Advanced critical thinking and technical writing skills.
• Strong organizational, communication, and interpersonal skills.

Compensation and Benefits

• Expected pay range per year: $70,000–$85,000
• 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.