Validation Program Manager Nutrition Manufacturing, Casa Grande, AZ

JOB DESCRIPTION:

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. Youll 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 bachelors 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 Abbotts leading nutrition manufacturing plants in the U.S. reflecting our commitment to innovation and excellence. But were more than just a company were a family. Working here youll be part of a family that works together to make a difference and enhance the lives of millions worldwide.

What Youll 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:

• Bachelors 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 crossfunctional collaboration.

Youll 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 ()

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

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 on Facebook at and on Twitter @AbbottNews.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

Manager