Validation Engineer
Abbott, Casa Grande, AZ, Onsite
Manufacturing ProductionBachelor RequiredMid Level
About the role
JOB DESCRIPTION:
Validation Engineer – Casa Grande, AZ Nutrition Plant
As the Validation Engineer, you will ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards.
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
- Review, guide, develop, assist in preparation, and support Design Qualification processes including:
- System Impact Assessments (SIA)
- Project Validation Plan (PVP)
- Failure Mode Effects Analysis (FMEA)
- User Requirement Specifications (URS) • Develop, execute and review validation protocols and related documentation in accordance with procedures and policies
- Support resolution of validation events and escalate concerns in a timely manner
- Execute assigned validation and change control activities in accordance with Abbott Nutrition policies, site procedures, and regulatory requirements (cGMP, GDP).
- Perform hands-on execution of validation protocols (IQ, OQ, PQ, CSV activities as applicable), including data collection, verification, and documentation under supervision of validation engineers or administrators.
- Compile, review for accuracy, and maintain validation documentation, ensuring completeness, traceability, and adherence to Good Documentation Practices
- Support change control activities, including impact assessments, documentation updates, and validation task execution related to equipment, systems, utilities, or process changes.
- Assist with investigation and resolution of validation deviations, discrepancies, and data issues; ensure proper documentation and timely escalation to responsible validation or quality personnel.
- Collaborate with Engineering, Quality, Operations, and IT teams to support validation tasks and project timelines.
- Support internal and external audits and inspections by providing documentation, records, and clarifications related to executed validation work.
- Perform other duties as assigned by Validation Engineering, Validation Administration, or Quality leadership
You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
Required Qualifications
- Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
- At least 2 - 4 years work experience in Quality, Validation, Engineering or related field in the food industry or industries with similar levels of regulatory oversight such as laboratory diagnostics, medical devices, pharmaceutical, etc.
- Strong understanding of Design Control, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
- Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
- Experienced in protocol writing and execution, closure of validation activities
Preferred Qualifications
- Self-starter with ability to achieve project goals with minimal management oversight.
- Act as a mentor and coach for a diverse team regarding validation, quality and compliance.
- Cultivate internal and external network of validation resources to complete tasks.
- Work independently and/or on project teams, with an ability to support a flexible work schedule.
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**](https://www.jobs.abbott/us/en)
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: [http://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 Employer, committed to employee diversity.
Connect with us at [abbott.com](https://www.abbott.com/), on LinkedIn at [https://www.linkedin.com/company/abbott-/](https://www.linkedin.com/company/abbott-/), and on Facebook at [https://www.facebook.com/AbbottCareers](https://www.facebook.com/AbbottCareers).