Transformation Project Qualification Lead- API

Role: Lead qualification efforts for strategic capital projects within AbbVie's Operations Transformation division, focusing on commissioning, qualification, and validation of equipment, facilities, and processes. Responsibilities: develop URS and FDS, support Factory Acceptance Testing, identify and document risk controls via FMEA, execute qualification and validation protocols, troubleshoot issues, and support project leadership and operational integration. Lead risk management activities, including periodic reviews and validation master plan adherence. Qualifications: Bachelor's in engineering, science, or related field; 3+ years of technical experience, with 6+ years in manufacturing, quality, or engineering, including validation expertise across at least four major subjects (e.g., equipment, computer, cleaning, process). Experience in regulated environments (pharma, biotech, medical devices), with knowledge of quality and compliance standards. Demonstrated ability to lead validation teams and manage complex projects. Preferred: background in healthcare, laboratory diagnostics, or similar industries; supervisory experience. HighValue: validation (qualification, commissioning, risk management), cGMP compliance, equipment and process validation, cross-functional project management within biopharma manufacturing. WorkSetup: not specified.