Engineer, Validation Commissioning

About AbbVie 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 including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio. Job Description Engineering professional who works with project owners, automation engineers, subject designers/engineers and other project team members to plan and complete tasks associated with commissioning, qualification and validation of new and modified automated systems, equipment, facilities, utilities, product processes, etc., in line with project, operations and quality objectives. Responsible for designing and executing evaluation, testing, and documentation strategies that support risk management, commissioning and validation in alignment with product, regulatory and quality requirements. Responsibilities Work with end‑user, project engineer, automation engineers and system owners to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities and utilities. Support Factory Acceptance Testing and related system verification activities to confirm equipment and automation solutions meet defined requirements before site deployment. Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment. Develop and execute commissioning, qualification and validation test protocols for equipment, utilities and automated or computer‑controlled systems to ensure performance against specifications. Perform minor troubleshooting of issues encountered during commissioning including control logic, integration, instrumentation, recipe/parameter settings, and documentation of unresolved issues. May support aspects of projects such as project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes. Supports execution of Risk Management including periodic review and update per the Validation Master Plan, interface with best practices, ccRA; understand risk management principles, documentation, controls, impact of change, trace controls and rating. May have Qualification as QRM facilitator commensurate with responsibility. Works with contract validation resources as part of a team in timely completion of activities in his/her area of responsibility. Qualifications Bachelor’s Degree in Engineering, Science or closely related discipline desired, or equivalent technical experience with demonstrated competence, and 1+ years of significant engineering and/or operational experience. Experience in development of commissioning, qualification, validation or risk management deliverables including specifications and testing protocols that can withstand regulatory scrutiny. Experience with Computer System Validation (CSV) required. 2+ years overall experience in Manufacturing, Quality or Engineering, including 2 major validation subjects (e.g., Computer, Equipment, Cleaning, Process). Experience working with automation systems, controls, PLC/SCADA, instrumentation, or computer-based process controls strongly preferred. Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceutical or similar industries preferred. Strong interpersonal, communication and negotiation skills with demonstrated ability to work within a team. Knowledge of quality/compliance management, regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred. Works with junior or contract team members as part of a team. Ability to manage multiple projects (3+) simultaneously. Benefits Competitive compensation with a base pay range that will vary by location. Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) for eligible employees. Short‑term incentive program eligibility. Equal Opportunity Employer – AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Veterans, Disabled and all qualified applicants are encouraged to apply. For U.S. and Puerto Rico applicants seeking a reasonable accommodation, please visit #J-18808-Ljbffr AbbVie