PAS-X EBR Engineer - GMP Compliance & Change Control

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

PTO

401K

Job summary

cGMP Consulting is seeking a motivated professional to manage electronic batch records (EBRs) within the PAS-X system, including template design, compliance oversight, and change control for manufacturing documentation.

This mid-level role emphasizes leadership in cross-functional collaboration, troubleshooting, and EBR release activities while applying a strong understanding of cGMP and 21 CFR Part 11. This contract-to-hire position is located in Melrose Park, IL.

Qualifications

• Bachelor's degree in Engineering, IT, CS or related field.
• Programming or configuration experience with PAS-X in pharmaceutical settings.
• Knowledge of 21 CFR Part 11 and data integrity for electronic records.
• Strong organizational, communication, and interpersonal skills.

Responsibilities

• Generate and design executable electronic batch records (EBRs) within PAS-X for shop floor manufacturing operations.
• Create, revise, and maintain SOPs related to batch record design and execution.
• Design and implement continuous improvement initiatives for batch documentation and workflows.
• Integrate PAS-X with SAP and an EDMS/document management system to support data flow.
• Lead EBR change control process with cross-functional teams.

Education

Bachelor's degree in Engineering, Information Technology, Computer Science, or related field

Tools

PAS-X

SAP

EDMS

Database

Virtual machines

Job description

cGMP Consulting is seeking a motivated professional to manage electronic batch records (EBRs) within the PAS-X system, including template design, compliance oversight, and change control for manufacturing documentation.

This mid-level role emphasizes leadership in cross-functional collaboration, troubleshooting, and EBR release activities while applying a strong understanding of cGMP and 21 CFR Part 11. This contract-to-hire position is located in Melrose Park, IL.