Senior Engineer, Validation

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 Tik Tok.

Job Description

The Senior Validation Engineer for Facilities Utilities & Equipment (FUE) Qualification is responsible for leading, planning, executing, and maintaining qualification/validation activities at AbbVie’s manufacturing site. This role ensures that all systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality standards, and industry best practices.

The successful candidate will serve as the subject matter expert (SME) for equipment, facility and utility validation, lead cross-functional projects, and drive continuous improvement in validation strategies and lifecycle management.

This position is fully onsite Monday-Friday. Open to considering non-local candidates; relocation required. 

Responsibilities:

• Lead and execute qualification activities for facility utilities and equipment, including but not limited to temperature-controlled chambers, water for injection, clean steam, process tanks, and autoclaves.
• Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.

• Identify risk controls, critical elements and traceability of equipment design based on the risk assessment.
• Develop, review, and approve validation protocols such as URS, FRS, DQ, IQ, OQ, PQ protocols as well as summary reports.

• Lead and document troubleshooting efforts of issues encountered during commissioning and qualification.
• Ensure risk-based validation approaches following current industry guidelines (e.g., GAMP 5, ASTM E2500, ISO, FDA, EMA).
• Support projects ensuring validation requirements are integrated into project deliverable