Engineer, Validation Commissioning
AbbVie
August 12, 2026
Remote friendly (North Chicago, IL)
United States
$65,500 - $125,500 USD yearly
Operations
Responsibilities:
- Work with end-user and project engineers, automation engineers, and system owners to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing and related system verification to confirm equipment/automation meet defined requirements before site deployment.
- Identify risk controls, critical elements, and design traceability based on FMEA or other risk assessments.
- Develop and execute commissioning, qualification, and validation test protocols for equipment, utilities, and automated/computer-controlled systems.
- Perform minor commissioning troubleshooting (control logic, integration, instrumentation, recipe/parameter settings) and document unresolved issues.
- May support project leadership, operational procedure development, training for maintenance/technical staff/operators, product documentation review for compatibility, and equipment parameter/recipe changes.
- Support risk management execution (periodic review/update per Validation Master Plan, best practices/ccRA), including understanding controls and change impact; may perform FMEA authorization/facilitation.
- May serve as Qualification Risk Management (QRM) facilitator.
- Work with contract validation resources to complete activities in assigned area.
Qualifications:
- Bachelor’s in Engineering/Science (or closely related) desired; or equivalent technical experience; 1+ years significant engineering/operational experience preferred.
- Experience developing commissioning, qualification, validation, and/or risk management deliverables (specifications and testing protocols) suitable for regulatory scrutiny.
- Computer System Validation (CSV) experience required.
- 2+ years manufacturing, quality, or engineering experience; 2 major validation subjects preferred.
- Strong preference for experience with automation systems/controls, PLC/SCADA, instrumentation, or computer-based process controls.
- Preferred technical background in healthcare/nutritional products/lab diagnostics/medical devices/pharmaceuticals or similar.
- Strong interpersonal, communication, and negotiation skills; able to manage multiple projects (3+) simultaneously.
Preferred skills:
- Quality/compliance management knowledge and regulations/standards affecting API, bulk drug, or finished goods manufacturing.
- Ability to work with junior/contract team members.
- Work with end-user and project engineers, automation engineers, and system owners to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing and related system verification to confirm equipment/automation meet defined requirements before site deployment.
- Identify risk controls, critical elements, and design traceability based on FMEA or other risk assessments.
- Develop and execute commissioning, qualification, and validation test protocols for equipment, utilities, and automated/computer-controlled systems.
- Perform minor commissioning troubleshooting (control logic, integration, instrumentation, recipe/parameter settings) and document unresolved issues.
- May support project leadership, operational procedure development, training for maintenance/technical staff/operators, product documentation review for compatibility, and equipment parameter/recipe changes.
- Support risk management execution (periodic review/update per Validation Master Plan, best practices/ccRA), including understanding controls and change impact; may perform FMEA authorization/facilitation.
- May serve as Qualification Risk Management (QRM) facilitator.
- Work with contract validation resources to complete activities in assigned area.
Qualifications:
- Bachelor’s in Engineering/Science (or closely related) desired; or equivalent technical experience; 1+ years significant engineering/operational experience preferred.
- Experience developing commissioning, qualification, validation, and/or risk management deliverables (specifications and testing protocols) suitable for regulatory scrutiny.
- Computer System Validation (CSV) experience required.
- 2+ years manufacturing, quality, or engineering experience; 2 major validation subjects preferred.
- Strong preference for experience with automation systems/controls, PLC/SCADA, instrumentation, or computer-based process controls.
- Preferred technical background in healthcare/nutritional products/lab diagnostics/medical devices/pharmaceuticals or similar.
- Strong interpersonal, communication, and negotiation skills; able to manage multiple projects (3+) simultaneously.
Preferred skills:
- Quality/compliance management knowledge and regulations/standards affecting API, bulk drug, or finished goods manufacturing.
- Ability to work with junior/contract team members.