Cleaning Validation & Commissioning Specialist
AbbVie
August 21, 2026
On-site
North Chicago, IL
$84,500 - $162,000 USD yearly
Operations
Job Description
An engineering professional who plans and completes commissioning, qualification, and validation (CQV) tasks for new and 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 to ensure robust, high-quality products.
Responsibilities
- Develop and execute CQV test protocols.
- Support broader project needs: project leadership, develop operational procedures, train staff/operators on new equipment/processes, review product documentation for compatibility, and implement changes.
- Lead execution of risk management, including periodic review/update per the Validation Master Plan; interface with best practices; establish team/work practices.
- Apply risk management principles (e.g., controls, change impact, trace controls); estimate ratings; demonstrate success in FMEA authorization/facilitation.
- May supervise contract validation resources.
- Coordinate and execute sampling for cleaning validation; document results and complete cleaning validation summary reports.
- Generate and process change requests.
- Lead special projects related to cleaning validation.
- Prepare area reports and presentations as applicable.
- Support operations with EH&S systems; comply with incident reporting, PPE, waste management/disposal; promote continuous improvement.
Qualifications
- Bachelor’s degree in engineering/science (or closely related) or equivalent technical experience; desired 3+ years engineering/operational experience.
- Experience developing commissioning/qualification/validation and risk management deliverables (specifications, testing protocols) suitable for regulatory scrutiny.
- 6+ years in Manufacturing, Quality, or Engineering (preferred); 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; ability to work in a team.
- Preferred knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or Finished goods.
- Ability to supervise junior/contract team members (prior supervisory experience preferred).
- Ability to manage complex/multiple projects (5+).
An engineering professional who plans and completes commissioning, qualification, and validation (CQV) tasks for new and 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 to ensure robust, high-quality products.
Responsibilities
- Develop and execute CQV test protocols.
- Support broader project needs: project leadership, develop operational procedures, train staff/operators on new equipment/processes, review product documentation for compatibility, and implement changes.
- Lead execution of risk management, including periodic review/update per the Validation Master Plan; interface with best practices; establish team/work practices.
- Apply risk management principles (e.g., controls, change impact, trace controls); estimate ratings; demonstrate success in FMEA authorization/facilitation.
- May supervise contract validation resources.
- Coordinate and execute sampling for cleaning validation; document results and complete cleaning validation summary reports.
- Generate and process change requests.
- Lead special projects related to cleaning validation.
- Prepare area reports and presentations as applicable.
- Support operations with EH&S systems; comply with incident reporting, PPE, waste management/disposal; promote continuous improvement.
Qualifications
- Bachelor’s degree in engineering/science (or closely related) or equivalent technical experience; desired 3+ years engineering/operational experience.
- Experience developing commissioning/qualification/validation and risk management deliverables (specifications, testing protocols) suitable for regulatory scrutiny.
- 6+ years in Manufacturing, Quality, or Engineering (preferred); 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; ability to work in a team.
- Preferred knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or Finished goods.
- Ability to supervise junior/contract team members (prior supervisory experience preferred).
- Ability to manage complex/multiple projects (5+).