Senior Validation Engineer - Columbus, OH

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Senior Validation Engineer About Abbott   Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help get the nutrients they need to live their healthiest life.  Working at Abbott   At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:  Career development with an international company where you can grow the career you dream of.  Free medical coverage for employees* via the Health Investment Plan (HIP) PPO  An excellent retirement savings plan with high employer contribution  Tuition reimbursement, the  Freedom 2 Save  student debt program and  FreeU  education benefit - an affordable and convenient path to getting a bachelor’s degree.  A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.   A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.   The stability of a company  with a record of strong financial performance and history of being actively involved in local communities  WHAT YOU’LL DO: As a Senior Validation Engineer, you will: Manage Validation Program:  Oversee the validation program for Strategic Capacity Expansions to ensure the success of large-scale capital projects. Develop Validation Strategy:  Create and align validation strategies for multi-million-dollar capital investments across all design phases. Provide Guidance:  Offer expertise on validation, design control strategies, and changes to products, processes, and equipment.

Management:  Lead project validation and engineering teams (internal, external, VSPs) to ensure successful execution. Monitor Progress:  Develop metrics to track progress, adherence, and compliance of validation and design control processes; escalate issues as needed. Navigate Challenges:  Resolve conflicts between project execution and policy requirements to achieve compliant outcomes. Support Resource Planning:  Assist PM with validation resource planning, scheduling, and support structure. Ensure Quality and Compliance:  Support the development and delivery of quality, compliant documentation packages on time and cost-effectively. Policy and Procedure Compliance:  Ensure team adherence to policies, processes, and procedures for design control, process validation, and change control. Cross-Functional Collaboration:  Work with Technical, Engineering, Quality, and R&D to implement compliant product/process changes. Education and Training:  Provide visibility and training to ensure proper monitoring of CPPs and compliance with validation and design control regulations. SME Role:  Act as a Subject Matter Expert for validation, design control processes, statistical sampling plans, DOE, and FMEA. Root Cause Analysis:  Collaborate with the team to identify root causes of unexpected outcomes and develop compliant solutions. Strategic Decision Making:  Make strategic decisions for validation encompassing all