PAS-X EBR Engineer & Process Improvement Lead

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

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting is seeking a motivated professional to manage electronic batch records through the PAS-X system, including template design, compliance oversight, and change control for manufacturing documentation in a GMP environment.

The role emphasizes leadership in cross-functional collaboration, troubleshooting, and EBR release activities, with a strong grounding in cGMP and 21 CFR Part 11. This Contract to Hire position is based in Melrose Park, IL.

Qualifications

• A Bachelor's degree in engineering/IT/CS or related field.
• Experience with PAS-X or similar workflow automation in pharma.
• Knowledge of aseptic/terminally sterilized parenteral products.
• Database and virtualization experience.
• Understanding of 21 CFR Part 11 and data integrity for electronic records/e-signatures.
• Strong writing, communication, and organizational skills.

Responsibilities

• Generate and design executable EBRs within PAS-X for shop floor manufacturing.
• Create, revise, and maintain SOPs related to batch record design and execution.
• Design and implement continuous improvement for batch docs and workflows.
• Integrate PAS-X with SAP and an EDMS to support data flow across systems.
• Automate the integration of manufacturing equipment data into PAS-X.
• Monitor PAS-X KPIs and document findings.
• Lead cross-functional meetings and document action items.
• Manage EBR change control including impact assessments and approvals.
• Support ISO 50001 energy management system maintenance.
• Draft and investigate change controls and deviations related to EBRs.
• Provide PAS-X expertise and suggest process improvements.
• Maintain compliance with policies, cGMP, safety protocols.
• Use Word, Excel, DMS tools to complete tasks.
• Perform additional tasks as assigned.

Skills

21 CFR Part 11 data integrity

Technical writing

Organizational skills

Communication skills

Education

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

Tools

PAS-X

Database

Virtual Machines

Job description

cGMP Consulting is seeking a motivated professional to manage electronic batch records through the PAS-X system, including template design, compliance oversight, and change control for manufacturing documentation in a GMP environment.

The role emphasizes leadership in cross-functional collaboration, troubleshooting, and EBR release activities, with a strong grounding in cGMP and 21 CFR Part 11. This Contract to Hire position is based in Melrose Park, IL.