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Sr. Validation Engineer - onsite role in Columbus, OH

Location United States - Ohio - Columbus Category Quality
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JOB DESCRIPTION

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

The Sr. Validation Engineer plays a pivotal role for the Columbus manufacturing site. The role ensures the validation change management process follows the established policies and procedures with an emphasis on timely approvals and consistent approaches. The main functions are periodic review of existing validation packages, monitoring of active validation packages, setting expectations for validation packages, and ensuring compliant reviews are executed.

WHAT YOU’LL DO

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Assures that the plant validation program is executed consistently with the Abbott Validation Policies.
  • The Validation Engineer will be part of the Engineering Team reporting to the Strategic Engineering Manager
  • Manage and coordinate the Validation Change Control System, Validation Master Plan and associated schedule and all related documentation.
  • Facilitate and manage the Validation Review Board, ensuring they are trained in accordance to Validation Policies and Procedures.
  • Facilitate yearly training for the site through coordination with Division Validation resource
  • Responsible for the creation of validation packages and review of all validation protocols and packages.
  • SME for the QA IT Systems (M-FILES) through which Validation Change Control is documented.
  • This Job function will change where updated procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made.
  • This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises.
  • Review and mentor colleagues on Installation and Operational Qualification, Design Specification, and User Requirement Specifications 
  • This role provides 24/7 support of Columbus Plant, which requires occasional work outside of your typical business hours - this is occasional and may happen only a few times a year.

QUALIFICATIONS

  • Bachelor's Degree in Engineering, or similar relevant degree
  • 4+ years of relevant experience in Validation Engineering in manufacturing, food industry, or industries with similar levels of regulatory oversight such as laboratory diagnostics, medical devices, pharmaceutical, etc.
  • Experience and demonstrated competency in process validation/validation engineer required. We're looking for someone that can be a SME for the Columbus Plant, and has experience beyond just technical writing for Validation
  • Experienced in protocol writing and execution, closure of validation activities such as Installation / Operational Qualification (IOQ), Performance Qualification (PQ)
  • Experience writing and mentoring XFN partners on IQ/OQ/PQ
  • 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.
  • Application of knowledge in multiple disciplines, such as food science, microbiology, mechanical engineering etc.
  • Documentation skills must be such that logic to the conclusions is easily followed. Solid technical foundation is critical to success.
  • Ability to apply appropriate statistical methods to better understand and improve plant equipment and processes, evaluate new or changed equipment or processes and resolve quality problems.

PREFERRED QUALIFICATIONS

  • The A.S.Q. Certified Quality Engineering Certificate a plus
  • Experience in FDA audit support a plus

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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 $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.

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Job Id 31114120 Location United States - Ohio - Columbus Medical surveillance No Division ANSC Nutrition Supply Chain Travel No Additional Location Significant work activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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