Senior Engineer, Validation Commissioning
AbbVie
August 18, 2026
Remote friendly (North Chicago, IL)
United States
$84,500 - $162,000 USD yearly
Operations
Job Description
An engineering professional working with project owners, subject designers/engineers, and project team members to plan and complete tasks for commissioning, qualification, and validation of new/modified equipment, facilities, utilities, products, and processes in line with project, operations, and quality objectives. Establish evaluation, testing, and documentation for risk management, commissioning, and validation using product and regulatory requirements and risk management to deliver robust, high-quality products.
Responsibilities
- 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 to confirm unit acceptability.
- Identify risk controls, critical elements, and traceability based on FMEA or other risk assessment.
- Develop and execute commissioning/qualification/validation test protocols to verify performance to specifications.
- Perform minor troubleshooting during commissioning; document unresolved issues.
- Support broader project needs as needed (project leadership, operational procedures, training, product documentation compatibility, equipment parameter/recipe changes).
- Lead execution of risk management (periodic review/update per Validation Master Plan; interface with best practices; establish team work practices; support FMEA authorization/facilitation).
- Qualification as QRM facilitator commensurate with responsibility.
- May supervise contract validation resources.
Qualifications
- Bachelor’s in Engineering/Science or closely related field, or equivalent experience; desired 3+ years significant engineering/operational experience.
- Experience developing commissioning/qualification/validation and risk management deliverables (specifications, testing protocols) meeting regulatory scrutiny.
- 6+ years in Manufacturing, Quality, or Engineering; preferred 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
- Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceuticals (preferred).
- Strong interpersonal, communication, negotiation skills; team-focused.
- Knowledge of quality/compliance management and regulations/standards for API, Bulk Drug, or Finished goods manufacturing (preferred).
- Ability to supervise junior/contract team members (prior supervision preferred).
- Ability to manage complex projects and 5+ simultaneous projects.
An engineering professional working with project owners, subject designers/engineers, and project team members to plan and complete tasks for commissioning, qualification, and validation of new/modified equipment, facilities, utilities, products, and processes in line with project, operations, and quality objectives. Establish evaluation, testing, and documentation for risk management, commissioning, and validation using product and regulatory requirements and risk management to deliver robust, high-quality products.
Responsibilities
- 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 to confirm unit acceptability.
- Identify risk controls, critical elements, and traceability based on FMEA or other risk assessment.
- Develop and execute commissioning/qualification/validation test protocols to verify performance to specifications.
- Perform minor troubleshooting during commissioning; document unresolved issues.
- Support broader project needs as needed (project leadership, operational procedures, training, product documentation compatibility, equipment parameter/recipe changes).
- Lead execution of risk management (periodic review/update per Validation Master Plan; interface with best practices; establish team work practices; support FMEA authorization/facilitation).
- Qualification as QRM facilitator commensurate with responsibility.
- May supervise contract validation resources.
Qualifications
- Bachelor’s in Engineering/Science or closely related field, or equivalent experience; desired 3+ years significant engineering/operational experience.
- Experience developing commissioning/qualification/validation and risk management deliverables (specifications, testing protocols) meeting regulatory scrutiny.
- 6+ years in Manufacturing, Quality, or Engineering; preferred 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
- Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceuticals (preferred).
- Strong interpersonal, communication, negotiation skills; team-focused.
- Knowledge of quality/compliance management and regulations/standards for API, Bulk Drug, or Finished goods manufacturing (preferred).
- Ability to supervise junior/contract team members (prior supervision preferred).
- Ability to manage complex projects and 5+ simultaneous projects.