Senior Validation & Commissioning Engineer — Quality Impact

BioSpace; North Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

AbbVie in North Chicago, IL, seeks an engineering professional to plan and execute commissioning, qualification and validation of new or modified equipment, facilities, and processes. The role focuses on risk management, technical documentation and regulatory alignment to deliver robust, high-quality products.

Working with project owners and cross-functional teams, you will develop specifications, support FAT, identify risk controls and ensure traceability per validation plans, enabling

Qualifications

• Bachelor's Degree in Engineering, science, or related discipline; 3+ years of significant engineering/operational experience.
• Experience in commissioning, qualification, validation and risk management deliverables with regulatory scrutiny.
• 6+ years in Manufacturing, Quality or Engineering including 4 major validation subjects preferred.
• Technical background in healthcare, nutritional products, lab diagnostics, medical devices or pharmaceutical industries preferred.
• Strong interpersonal, communication, and negotiation skills with ability to work in a team.
• Knowledge of quality/compliance management and regulations affecting API, Bulk Drug or Finished goods manufacturing preferred.
• Ability to supervise junior or contract team members.
• Ability to manage multiple complex projects (5+) simultaneously.

Responsibilities

• Develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing in conjunction with Project Engineer.
• Identify risk controls and traceability based on FMEA or risk assessment.
• Develop and execute commissioning, qualification and validation test protocols.
• Troubleshoot issues and document unresolved items.
• Lead broader project aspects: leadership, operating procedures, training, reviewing documentation.
• Execute Risk Management per Validation Master Plan and assess change impacts.
• Supervise contract validation resources as needed.

Skills

Strong interpersonal skills

Effective communication

Negotiation skills

Project management

Education

Bachelor's Degree in Engineering or related discipline

Equivalent technical experience

Job description

AbbVie in North Chicago, IL, seeks an engineering professional to plan and execute commissioning, qualification and validation of new or modified equipment, facilities, and processes. The role focuses on risk management, technical documentation and regulatory alignment to deliver robust, high-quality products.

Working with project owners and cross-functional teams, you will develop specifications, support FAT, identify risk controls and ensure traceability per validation plans, enabling