Validation Engineer - Nutrition Plant - Casa Grande, AZ

Abbott Laboratories; Casa Grande (AZ); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

FreeU education benefit

Employer retirement contributions

Job summary

Abbott Laboratories, in Casa Grande, AZ, seeks a Validation Engineer to ensure timely change control and validation activities in the Abbott Nutrition division. You will work on Design Qualification, validation protocols, and documentation for new installations or major changes, aligning with Abbott policies and regulatory standards.

The role requires a Life Science or Engineering degree with 2+ years in quality/validation in regulated industries; strong GDP, cGMP knowledge, and protocol

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline.
• 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, 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.

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 accelerate concerns in a timely manner
• Comply to all policies and standards
• Any other requests as assigned by supervisor

Skills

Design Control

GDP

cGMP

GAMP5

FDA Computer Software Assurance

Microsoft Word

Microsoft Excel

Outlook

Education

Bachelor’s degree in Life Science, Engineering, or closely related discipline

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Validation Engineer – Casa Grande, AZ Nutrition Plant

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.

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.

What You’ll Work On

• 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 accelerate concerns in a timely manner

• Comply to all policies and standards

• Any other requests as assigned by supervisor

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

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)

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, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.