Validation Engineer

3 months ago


Casa Grande, United States Abbott Full time

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

Ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards.

Major Responsibilities

Lead and support Design Qualification processes including: System Impact Assessments (SIA), Project Validation Plan (PVP), Failure Mode Effects Analysis (FMEA), and User Requirement Specifications (URS) for new installations or major changes. 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 Comply to all policies and standards Any other requests as assigned by supervisor

Individual Skillset

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.

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 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.

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.

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