Engineer, Validation Commissioning

Agnello & Rogers; North Chicago (IL); On-site; USD 64,000 - 122,000; Full time

Job summary

A leading company in the healthcare sector is seeking an engineering professional to support commissioning and validation of equipment. The role involves collaboration with project teams to ensure compliance with regulatory standards and optimize systems for quality assurance. Candidates should possess a relevant Bachelor's degree and experience in engineering or operational roles.

Qualifications

• 1+ years of engineering and/or operational experience desired.
• 2+ years of experience in Manufacturing, Quality, or Engineering.
• Technical background in healthcare, nutritional products, or similar industries preferred.

Responsibilities

• Collaborate with end-users to develop specifications for new or modified equipment.
• Support Factory Acceptance Testing to ensure units meet acceptance criteria.
• Develop and execute commissioning, qualification, and validation test protocols.

Skills

Interpersonal skills

Communication

Negotiation

Risk management

Education

Bachelor’s Degree in Engineering, Science, or related discipline

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

Purpose

An engineering professional who works with project owners, subject designers/engineers, and other project team members to plan and complete tasks related to commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, and processes. The role aligns with project, operations, and quality objectives. The primary goal is to establish evaluation, testing, and documentation for risk management, commissioning, and validation, applying product and regulatory requirements to produce robust, high-quality products. This includes optimizing systems supporting this area of responsibility.

Responsibilities

1. Collaborate with end-users and project engineers to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
2. Support Factory Acceptance Testing alongside Project Engineers to ensure units meet acceptance criteria.
3. Identify risk controls, critical elements, and traceability of equipment design based on FMEA or other risk assessments.
4. Develop and execute commissioning, qualification, and validation test protocols to verify that units function according to specifications.
5. Perform minor troubleshooting during commissioning and document unresolved issues.
6. Support project aspects such as project leadership, developing operational procedures, training maintenance/technical staff/operators on new equipment, reviewing documentation for compatibility, and implementing changes.
7. Assist in executing Risk Management activities, including periodic reviews and updates per the Validation Master Plan, understanding risk management principles, controls, impact of changes, trace controls, and estimating ratings using appropriate scales. May facilitate FMEA processes.
8. Possibly qualify as a QRM facilitator, depending on responsibility.
9. Work with contract validation resources to ensure timely completion of activities within their area of responsibility.

Qualifications

• Bachelor’s Degree in Engineering, Science, or a related discipline preferred, or equivalent technical experience with demonstrated competence. 1+ years of significant engineering and/or operational experience desired.
• Experience in developing commissioning, qualification, validation, or risk management deliverables, including specifications and testing protocols that meet regulatory standards.
• 2+ years of experience in Manufacturing, Quality, or Engineering, including at least two major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
• Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceuticals, or similar industries preferred.
• Strong interpersonal, communication, and negotiation skills, with the ability to work effectively in a team environment.
• Knowledge of quality and compliance management, as well as regulations affecting API, bulk drugs, or finished goods manufacturing, preferred.
• Ability to manage multiple projects (3+) simultaneously.

Additional Information

Details about pay range, benefits, and employment conditions are provided, including eligibility for incentive programs and legal disclosures regarding compensation and accommodations.

AbbVie is an equal opportunity employer committed to integrity, innovation, transforming lives, and community service. For more information, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html and https://www.abbvie.com/join-us/reasonable-accommodations.html.

Compensation: $64,000-$122,000 per year