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 115,000 colleagues serve people in more than 160 countries.
Validation Program Manager - Nutrition Manufacturing, Casa Grande, AZ
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. 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 them get the nutrients they need to live their healthiest lives.
Casa Grande, AZ., is one of Abbott's leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we're more than just a company, we're a family. Working here you'll be part of a family that works together to make a difference and enhance the lives of millions worldwide.
What You'll Work On
Provide strategic leadership, oversight, and governance of site validation and change control activities to ensure regulatory compliance and alignment with Abbott Nutrition policies, standards, and business objectives.
Lead and prioritize validation programs to ensure timely execution, appropriate resourcing, and alignment with project schedules and operational needs.
Own Design Qualification strategy and execution, including review and approval of System Impact Assessments (SIA), Project Validation Plans (PVP), Failure Modes and Effects Analysis (FMEA), and User Requirement Specifications (URS) for new or modified systems, equipment, utilities, facilities, and processes.
Establish, maintain, and continuously improve site validation standards, procedures, and best practices to ensure consistency, compliance, and inspection readiness.
Review and approve validation protocols, reports, and documentation (IQ/OQ/PQ, CSV, etc.) in accordance with internal procedures and regulatory requirements (cGMP, FDA, GAMP).
Serve as the primary escalation point for validation deviations, nonconformances, and compliance risks; lead investigations and drive timely resolution and CAPA.
Partner cross-functionally with Engineering, Quality, Operations, IT, Project Management, and corporate teams to integrate validation requirements early into project planning and execution.
Lead, coach, and develop validation personnel through performance management, mentoring, workload planning, and capability development.
Act as the validation subject matter expert during internal, corporate, and regulatory audits; support inspection readiness and responses to observations related to validation and change control.
Monitor validation program performance through metrics and continuous improvement initiatives to enhance efficiency, compliance, and risk management.
Ensure compliance with all Abbott policies, procedures, safety requirements, and quality standards.
Build and maintain internal and external validation networks to support successful execution of site and enterprise initiatives.
Perform additional duties as assigned by site or quality leadership.
Required Qualifications:
Bachelor's degree in Life Sciences, Engineering, or a closely related discipline.
Minimum of 5 years of experience in Quality, Validation, Engineering, or a related function within the food industry or similarly regulated environments (e.g., pharmaceutical, medical devices, laboratory diagnostics).
Strong working knowledge of Design Controls, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
Experience with validation lifecycle activities, including protocol development, execution, and closure.
Familiarity with GAMP 5 principles; exposure to FDA Computer Software Assurance (CSA) initiatives is preferred.
Proficient in Microsoft Word, Excel, and Outlook for planning, documentation, reporting, and cross-functional collaboration.
You'll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission (eeoc.gov) (https://www.eeoc.gov/pre-employment-inquiries-and-citizenship)
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity and Military/Veteran friendly Employer, committed to employee diversity.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews.
The base pay for this position is $86,700.00 - $173,300.00. 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
