Senior Engineer, Validation

Role Summary

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, ensuring 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; relocation is required for non-local candidates.

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 deliverables and timelines are met.
• Coordinate with Engineering, Quality Assurance, Operations, and Maintenance to support commissioning, start-up, and qualification activities.
• Maintain validation status of systems through the execution of Periodic Reviews, Requalifications, and Change Controls.
• Maintain Validation Master Plans as appropriate. Participate in Validation Review Board meetings. Responsible for Validation Change Control documentation.
• Support regulatory inspections and internal audits related to equipment, utility, and facility qualification.

Qualifications

• Required: Bachelor’s Degree, a BS in an engineering discipline
• Required: 5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area
• Required: Knowledge/experience in creating and executing validation documents
• Required: General understanding of pharmaceutical equipment
• Preferred: Experience with clean utilities (e.g., WFI, PW, Clean Steam), facility monitoring systems, and critical environment controls
• Preferred: Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny
• Preferred: Experience in Manufacturing including 5 major validation subjects
• Preferred: Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing
• Preferred: Strong knowledge of qualification and validation lifecycle principles and applicable regulatory guidelines (FDA, EMA, ICH Q7/Q9/Q10, GAMP 5, ASTM E2500)
• Preferred: Sterile manufacturing qualification experience
• Preferred: Quality System Experience such as Veeva, Trackwise, ComplianceWire
• Preferred: Ability to manage complex projects and multiple projects (5+) simultaneously
• Preferred: Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment
• Preferred: Hands-on experience with FUE systems and process equipment qualification
• Preferred: Excellent technical writing, analytical, and problem-solving skills
• Preferred: Experience with computerized system validation (CSV) and automation platforms