Validation Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

This position works out of our Columbus, Ohio plant 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.

The Columbus Plant is Abbott’s first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you’ll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

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

• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Vacation – 120 hours of accrued vacation (1st yr is prorated) vacation buy program 3 personal days 10 paid holidays
• Retiree Healthcare program
• Robust 401(k) retirement savings with a generous company match
• 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 around the world and named one of the most admired companies in the world by Fortune.
• A stable company with a record of strong financial performance and history of being actively involved in local communities
• 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

Coordinates schedules and implementing activities for the Distribution function, that include overseeing personnel, directing operations and following-up on transactions, to ensure department standards and the Regulations are observed. Manages sterilization, returned goods, receipt, storage and transaction of finished goods in accordance with validated procedures. Ensures that customer orders are processed quickly and accurately to meet Division standards.

What You’ll Do

• As a Validation Engineer, you’ll have the chance to create and implement the Abbott Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.
• Ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards.
• Lead and support Design Qualification processes including: Installation / Operational Qualification (IOQ), Performance Qualification (PQ), System Impact Assessments (SIA), Project Validation Plan (PVP), Failure Mode Effects Analysis (FMEA), and User Requirement Specifications (URS) for new installations or major changes.
• Strong understanding and implementation of the CAPA management system
• Develop, execute and review FDA 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 FDA policies and standards
• Use M-Files to house all validation and control documentation
• Any other requests as assigned by supervisor
  
  

Required Qualifications

• A Bachelor’s Degree , preferred degree in engineering or technical field.
• 3-5 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.
• Experienced in protocol writing and execution, closure of validation activities such as Installation / Operational Qualification (IOQ), Performance Qualification (PQ
• Ability to execute findings and develop project scope for execution.
• Drive to lead projects and understand project timelines.
  
  

Preferred Qualifications

• Experience in an FDA regulated environment.
• Experience in Chemical, Mechanical, Quality, or Validation Engineering
  
  

Apply Now

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)

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

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  
  

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 and a Military/Veteran friendly Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.