Transformation Project Qualification Lead
AbbVie
August 22, 2026
Remote friendly (North Chicago, IL)
United States
$84,500 - $162,000 USD yearly
IT
Responsibilities:
- Work with end-users and project engineers to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing (FAT) with the Project Engineer.
- Identify risk controls, critical elements, and design traceability using FMEA or other risk assessments.
- Develop and execute commissioning, qualification, and validation (CQV) test protocols to ensure equipment functions per specifications.
- Perform minor troubleshooting during commissioning and document unresolved issues.
- Support broader project needs as required: project leadership, operational procedure development, training maintenance/technical staff/operators, reviewing product documentation for compatibility, and implementing equipment parameter/recipe changes.
- Lead execution of risk management (periodic review/update per Validation Master Plan), including FMEA authorization/facilitation.
- Qualify as QRM facilitator commensurate with responsibility.
- May supervise contract validation resources.
Qualifications:
- Bachelor’s Degree in Engineering/science or related field (or equivalent technical experience); desired 3+ years significant engineering/operational experience.
- Experience developing CQV and risk management deliverables (specifications/testing protocols) that meet regulatory scrutiny.
- Preferred: 6+ years overall Manufacturing, Quality, or Engineering experience, including 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
- Preferred technical background in healthcare, nutritional products, lab diagnostics, medical devices, pharmaceuticals, or similar.
- Strong interpersonal, communication, and negotiation skills.
- Preferred knowledge of quality/compliance management and regulations/standards for API, bulk drug, or finished goods manufacturing.
- Ability to supervise junior/contract team members (preferred).
- Ability to manage complex projects and multiple initiatives (5+).
- Work with end-users and project engineers to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing (FAT) with the Project Engineer.
- Identify risk controls, critical elements, and design traceability using FMEA or other risk assessments.
- Develop and execute commissioning, qualification, and validation (CQV) test protocols to ensure equipment functions per specifications.
- Perform minor troubleshooting during commissioning and document unresolved issues.
- Support broader project needs as required: project leadership, operational procedure development, training maintenance/technical staff/operators, reviewing product documentation for compatibility, and implementing equipment parameter/recipe changes.
- Lead execution of risk management (periodic review/update per Validation Master Plan), including FMEA authorization/facilitation.
- Qualify as QRM facilitator commensurate with responsibility.
- May supervise contract validation resources.
Qualifications:
- Bachelor’s Degree in Engineering/science or related field (or equivalent technical experience); desired 3+ years significant engineering/operational experience.
- Experience developing CQV and risk management deliverables (specifications/testing protocols) that meet regulatory scrutiny.
- Preferred: 6+ years overall Manufacturing, Quality, or Engineering experience, including 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
- Preferred technical background in healthcare, nutritional products, lab diagnostics, medical devices, pharmaceuticals, or similar.
- Strong interpersonal, communication, and negotiation skills.
- Preferred knowledge of quality/compliance management and regulations/standards for API, bulk drug, or finished goods manufacturing.
- Ability to supervise junior/contract team members (preferred).
- Ability to manage complex projects and multiple initiatives (5+).