EBR Engineer - PAS-X, GMP Compliance & Change Control

cGMP Consulting Inc.; Melrose Park (IL); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

PTO

401K

Job summary

cGMP Consulting Inc. is seeking a mid-level professional to manage electronic batch records (EBR) through PAS-X, including design, compliance oversight, and change control in a GMP manufacturing environment.

The role emphasizes leading cross-functional collaboration, troubleshooting, and EBR release activities while maintaining independence and knowledge of cGMP and FDA 21 CFR Part 11 guidelines. This is a contract-to-hire position in Melrose Park, IL.

Qualifications

• Bachelor’s degree in engineering, IT, CS or related field.
• Experience configuring PAS-X workflows in a pharmaceutical setting.
• Knowledge of 21 CFR Part 11 and data integrity requirements.
• Strong writing, communication, and organizational skills.

Responsibilities

• Design and generate executable EBRs in PAS-X for shop floor operations.
• Draft and update SOPs related to batch records and execution.
• Lead continuous improvement initiatives for batch docs and workflows.
• Test and validate EBR templates with cross-functional teams.
• Coordinate EBR change control and deviation investigations.
• Integrate PAS-X with SAP and EDMS for seamless data flow.

Skills

GMP knowledge

Analytical thinking

Technical writing

Project coordination

Cross-functional collaboration

Troubleshooting

Change management

Education

Bachelor’s degree in Engineering/IT/CS

Tools

PAS-X

SAP

EDMS

Document Management Systems

Databases

Job description

cGMP Consulting Inc. is seeking a mid-level professional to manage electronic batch records (EBR) through PAS-X, including design, compliance oversight, and change control in a GMP manufacturing environment.

The role emphasizes leading cross-functional collaboration, troubleshooting, and EBR release activities while maintaining independence and knowledge of cGMP and FDA 21 CFR Part 11 guidelines. This is a contract-to-hire position in Melrose Park, IL.