Validation & Commissioning Engineer

BioSpace; North Chicago (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

AbbVie seeks an engineering professional to plan and execute commissioning, qualification, and validation of automated systems, facilities, utilities, and processes in alignment with regulatory and quality requirements. You will design robust evaluation, testing, and documentation strategies while optimizing workflows for reliable manufacturing operations.

Responsibilities include developing specs, performing FAT, identifying risk controls via FMEA, and executing validation protocols.

Qualifications

• Bachelor's degree in Engineering or related field; 1+ years of significant engineering/operational experience.
• Experience developing commissioning, qualification, validation, or risk deliverables.
• Experience with Computer System Validation (CSV) is required.
• 2+ years in Manufacturing, Quality or Engineering with 2 major validation subjects preferred.
• Experience with automation systems, controls, PLC/SCADA, instrumentation.
• Healthcare/pharma industry background preferred.
• Strong interpersonal, communication, and teamwork skills.
• Ability to manage multiple projects (3+) simultaneously.

Responsibilities

• Develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
• Support Factory Acceptance Testing and verification activities to confirm facility and utility systems meet defined requirements prior to site deployment.
• Identify risk controls, critical elements, and traceability based on FMEA or risk assessments for qualified facilities and utility systems.
• Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, HVAC systems, and environmental/viable monitoring systems.
• Perform minor troubleshooting during commissioning including control logic, integration, instrumentation, documentation, and qualification deliverables.
• May support project activities such as leadership, SOPs, training, and documentation reviews; implement changes to equipment parameters or settings.
• Support risk management activities, including review per Validation Master Plan and interface with best practices; may perform FMEA facilitation.

Skills

Automation systems

PLC/SCADA

Instrumentation

Team collaboration

Regulatory knowledge

Risk management

Education

Bachelor's degree in Engineering/related field

Tools

CSV

FMEA

Job description

AbbVie seeks an engineering professional to plan and execute commissioning, qualification, and validation of automated systems, facilities, utilities, and processes in alignment with regulatory and quality requirements. You will design robust evaluation, testing, and documentation strategies while optimizing workflows for reliable manufacturing operations.

Responsibilities include developing specs, performing FAT, identifying risk controls via FMEA, and executing validation protocols.