Senior Validation & Commissioning Engineer

Artha Nexgen; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Senior Engineer, Validation Commissioning to lead commissioning, qualification and validation activities for new and modified equipment, facilities, and utilities at our Kentucky site. You will work with project owners and design teams to develop specifications, execute test protocols and manage risk controls to ensure compliant, high-quality products.

The role emphasizes regulatory readiness, collaboration with maintenance and operations, and leadership in validation

Qualifications

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience with 3+ years of significant engineering/operational experience.
• Experience developing commissioning, qualification, validation and risk management deliverables to withstand regulatory scrutiny.
• 6+ years total experience in Manufacturing, Quality or Engineering with 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).

Responsibilities

• Develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing with Project Engineer to confirm unit acceptability.
• Identify risk controls and traceability of equipment design per FMEA or other risk assessments.
• Develop and execute commissioning, qualification and validation tests to ensure units meet specifications.
• Lead risk management activities per the Validation Master Plan and support project leadership as needed.

Skills

Interpersonal skills

Communication

Negotiation

Education

Bachelor's Degree in Engineering

Job description

AbbVie is seeking a Senior Engineer, Validation Commissioning to lead commissioning, qualification and validation activities for new and modified equipment, facilities, and utilities at our Kentucky site. You will work with project owners and design teams to develop specifications, execute test protocols and manage risk controls to ensure compliant, high-quality products.

The role emphasizes regulatory readiness, collaboration with maintenance and operations, and leadership in validation