Validation Engineer - Casa Grande, AZ

Abbott • Casa Grande, AZ

1d • $61,300 - $122,700 • Onsite

About The Position

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. 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.

Requirements

• 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).
• Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
• Experienced in protocol writing and execution, closure of validation activities

Nice To Haves

• Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level