Senior Engineer, Validation

Senior Validation Engineer – Facilities Utilities & Equipment (FUE) Qualification

Company:
Abb Vie

Location:

Onsite, Monday – Friday; relocation may be required.

The Senior Validation Engineer will lead, plan, execute, and maintain qualification/validation activities at Abb Vie's manufacturing site, ensuring all systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality standards, and industry best practices.

• Lead and execute qualification activities for facility utilities and equipment, including 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 risk assessment.
• Develop, review, and approve validation protocols such as URS, FRS, DQ, IQ, OQ, PQ protocols and 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 and 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.

• Bachelor’s Degree, BS in an engineering discipline.
• 5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
• Knowledge/experience in creating and executing validation documents.
• General understanding of pharmaceutical equipment.

• Experience with clean utilities (e.g., WFI, PW, Clean Steam), facility monitoring systems, and critical environment controls.
• Experience in the development of commissioning, qualification, validation and risk management deliverables that can stand up to regulatory scrutiny.
• Experience in Manufacturing including 5 major validation subjects.
• Knowledge of quality/compliance management and regulations affecting API, Bulk Drug or Finished goods manufacturing.
• Strong knowledge of qualification and validation lifecycle principles and applicable regulatory guidelines (FDA, EMA, ICH Q7/Q9/Q10, GAMP 5, ASTM E2500).
• Sterile manufacturing qualification experience preferred.
• Quality System Experience such as Veeva, Trackwise, Compliance Wire.
• Ability to manage complex projects and multiple projects (5+) simultaneously.
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• Hands‑on experience with FUE systems and process equipment qualification.
• Excellent technical writing, analytical, and problem‑solving skills.
• Experience with computerized system validation (CSV) and automation platforms.

Compensation range:
The range of possible base pay compensation that Abb Vie believes in good faith it will pay for this role, subject to change. Individual compensation paid within this range will depend on many factors including geographic location, and Abb Vie may pay more or less than the posted range.

Comprehensive benefits package includes paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees. The job qualifies for short‑term incentive programs.

Abb Vie is an Equal‑Opportunity Employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.