Senior Validation & Commissioning Engineer (Pharma)

Regulatory Jobs; North Chicago (IL); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Job summary

AbbVie is seeking an engineering professional to plan and complete commissioning, qualification and validation activities for equipment, facilities and processes. The role emphasizes risk management, documentation, and ensuring regulatory compliance to deliver robust, high-quality products.

You'll lead validation efforts, collaborate across project teams, and coordinate contract resources while supporting environmental, health and safety programs.

Qualifications

• Bachelor's Degree in Engineering or related field with 3+ years of engineering/operational experience.
• Experience developing commissioning, qualification, validation and risk management deliverables for regulatory scrutiny.
• 6+ years in Manufacturing, Quality or Engineering with 4 major validation subjects preferred.
• Technical background in healthcare/pharmaceutical or related industries preferred.
• Strong interpersonal, communication and negotiation skills; team-oriented.
• Knowledge of quality/compliance management and API/Bulk Drug/Finished goods regulations.
• Ability to supervise junior or contract team members.
• Ability to manage complex projects and multiple projects (5+) simultaneously.

Responsibilities

• Develop and execute commissioning, qualification and validation test protocols.
• Support broader project aspects including leadership, operational procedures, staff training on new equipment or processes.
• Lead risk management execution and maintain validation master plan alignment.
• Review documentation, assess controls, change impact, and estimate ratings; facilitate FMEA.
• Supervise contract validation resources as needed.
• Coordinate sampling for cleaning validation and prepare related reports.
• Generate and process change requests; lead related projects.
• Prepare area reports and presentations; support EH&S compliance.

Skills

Validation

Risk management

Project leadership

Quality compliance

Supervisory

Cross-functional

Education

Bachelor's degree in Engineering

Job description

AbbVie is seeking an engineering professional to plan and complete commissioning, qualification and validation activities for equipment, facilities and processes. The role emphasizes risk management, documentation, and ensuring regulatory compliance to deliver robust, high-quality products.

You'll lead validation efforts, collaborate across project teams, and coordinate contract resources while supporting environmental, health and safety programs.