Cleaning Validation & Commissioning Specialist

AbbVie seeks an engineering professional to develop and execute commissioning, qualification, and validation protocols for equipment, facilities, and processes. The role involves risk management leadership, cleaning validation oversight, and coordination with cross-functional project teams to ensure regulatory compliance and product quality.

Responsibilities

• Develop and execute commissioning, qualification, and validation test protocols and documentation
• Lead risk management activities including FMEA facilitation, controls assessment, and validation master plan updates
• Coordinate and execute cleaning validation sampling, documentation, and summary report completion
• Support broader project activities including operational procedures, staff training, and change implementation
• Supervise contract validation resources and lead special projects related to cleaning validation

Requirements

• Bachelor's degree in engineering, science, or related discipline; or equivalent technical experience
• 3+ years of engineering and/or operational experience
• 6+ years in manufacturing, quality, or engineering with four major validation subjects
• Experience developing validation, qualification, and risk management deliverables for regulatory submission
• Knowledge of quality, compliance, regulations, and standards for pharmaceutical or related manufacturing
• Strong interpersonal, communication, and negotiation skills with team collaboration ability
• Ability to manage multiple complex projects simultaneously and supervise junior or contract staff