Abbott Validation Engineer- FDA Validation- Columbus Ohio in Columbus, Ohio
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 115,000 colleagues serve people in more than 160 countries.
Nourish the world and your career as part of the Nutrition team at Abbott.
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®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Fast-paced work environment where your safety is our priority
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
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
Vacation – 3 weeks of accrued vacation (1 st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
Company Paid Pension Plan
401(k) retirement savings with a generous company match
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
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
EDUCATION AND EXPERIENCE YOU’LL BRING
A Bachelor’s Degree , preferred degree in engineering or technical field.
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.
Prior experience as a Sr. Quality Engineer in an FDA regulated environment.
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Abbott is a veteran / US military-friendly employer.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org
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