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 114,000 colleagues serve people in more than 160 countries. **Nourish the world and your career as part of the Nutrition team at Abbott.** Our 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®, Glucerna® – to help get the nutrients they need to live their healthiest life. **WHAT WE OFFER** At Abbott, you can have a good job that can grow into a great career. We offer: + **A fast-paced work environment** where your safety is our priority + Production areas that are **clean, well-lit and temperature-controlled** + **Training and career development** , with onboarding programs for new employees and tuition assistance + **Financial security** through competitive compensation and incentives + **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs + **Paid time off** + **401(k)** retirement savings with a generous company match + **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities **Learn more about our benefits that add real value to your life to help you live fully:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) **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. + **Team 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 project phases and resource allocation. + **Leadership:** Lead a team, ensuring adherence to the Abbott Code of Conduct and maintaining validation competency. + **Documentation Oversight:** Oversee review and approval of change processes, validation packages, and design control documentation. + **Best Practices:** Collaborate with corporate, divisional, and capacity expansion teams to utilize and improve validation and design control policies. + **Budget Management:** Manage the validation budget, ensuring spending within limits and supporting cost-efficient business processes. + **Travel:** 20-40% travel is expected as part of this role. **EDUCATION AND EXPERIENCE YOU'LL BRING:** **Required:** + Bachelor’s degree in Life Science, Engineering, or closely related discipline is required. + 5+ years’ experience in commissioning, qualification and validation (preferably with bulk liquid processing, aseptic processing, Clean-In-Place (CIP), evaporation, spray drying, dry blending, and/or powder handling unit operations in the food/pharma/nutrition industries). + Strong understanding of Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and 21 CFR Part 11. Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred. + Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating. Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com