Engineer, Validation Commissioning
AbbVie
August 12, 2026
On-site
North Chicago, IL
$65,500 - $125,500 USD yearly
Operations
Job Description
An engineering professional who plans and completes tasks associated with commissioning, qualification, and validation of new and modified automated systems equipment, facilities, utilities, product, and processes in line with project, operations, and quality objectives. Designs and executes evaluation, testing, and documentation strategies supporting risk management, commissioning, and validation aligned with product, regulatory, and quality requirements. Optimizes automated systems, process controls, and technical workflows to support reliable and compliant manufacturing operations.
Responsibilities
- Develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
- Support Factory Acceptance Testing and verification prior to site deployment.
- Identify risk controls, critical elements, and traceability of design requirements using FMEA or other risk assessment methods.
- Develop and execute commissioning/qualification/validation protocols for facilities, utilities, HVAC, and environmental/viable monitoring systems.
- Perform minor troubleshooting during commissioning (control logic, integration, instrumentation, documentation, qualification deliverables).
- May support project leadership, operational procedure development, training, documentation review, and parameter/settings changes.
- Support risk management activities (Validation Master Plan reviews/updates, best practices/ccRA interface, trace/change impact/rating scales; may perform FMEA authorization/facilitation).
- May serve as a QRM facilitator.
- Work with contract validation resources to complete qualification activities.
Qualifications
- Bachelor’s in Engineering/science (or equivalent) with desired 1+ years significant engineering and/or operational experience.
- Experience developing commissioning/qualification/validation and/or risk management deliverables with regulatory-scrutiny-ready specifications and testing protocols.
- Computer System Validation (CSV) experience required.
- 2+ years in Manufacturing, Quality, or Engineering; 2 major validation subjects preferred.
- Strongly preferred: automation systems/controls, PLC/SCADA, instrumentation, computer-based process controls.
- Preferred technical background: healthcare, nutritional products, lab diagnostics, medical devices, pharmaceutical, or similar.
- Strong communication/interpersonal skills; ability to work in teams.
- Preferred: knowledge of quality/compliance management and standards affecting API/Bulk Drug/Finished goods manufacturing.
- Ability to manage multiple projects (3+) simultaneously; works with junior/contract team members.
An engineering professional who plans and completes tasks associated with commissioning, qualification, and validation of new and modified automated systems equipment, facilities, utilities, product, and processes in line with project, operations, and quality objectives. Designs and executes evaluation, testing, and documentation strategies supporting risk management, commissioning, and validation aligned with product, regulatory, and quality requirements. Optimizes automated systems, process controls, and technical workflows to support reliable and compliant manufacturing operations.
Responsibilities
- Develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
- Support Factory Acceptance Testing and verification prior to site deployment.
- Identify risk controls, critical elements, and traceability of design requirements using FMEA or other risk assessment methods.
- Develop and execute commissioning/qualification/validation protocols for facilities, utilities, HVAC, and environmental/viable monitoring systems.
- Perform minor troubleshooting during commissioning (control logic, integration, instrumentation, documentation, qualification deliverables).
- May support project leadership, operational procedure development, training, documentation review, and parameter/settings changes.
- Support risk management activities (Validation Master Plan reviews/updates, best practices/ccRA interface, trace/change impact/rating scales; may perform FMEA authorization/facilitation).
- May serve as a QRM facilitator.
- Work with contract validation resources to complete qualification activities.
Qualifications
- Bachelor’s in Engineering/science (or equivalent) with desired 1+ years significant engineering and/or operational experience.
- Experience developing commissioning/qualification/validation and/or risk management deliverables with regulatory-scrutiny-ready specifications and testing protocols.
- Computer System Validation (CSV) experience required.
- 2+ years in Manufacturing, Quality, or Engineering; 2 major validation subjects preferred.
- Strongly preferred: automation systems/controls, PLC/SCADA, instrumentation, computer-based process controls.
- Preferred technical background: healthcare, nutritional products, lab diagnostics, medical devices, pharmaceutical, or similar.
- Strong communication/interpersonal skills; ability to work in teams.
- Preferred: knowledge of quality/compliance management and standards affecting API/Bulk Drug/Finished goods manufacturing.
- Ability to manage multiple projects (3+) simultaneously; works with junior/contract team members.