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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.

Senior Validation Quality Engineer

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.

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 get the nutrients they need to live their healthiest life.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• 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 – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays

• 401(k) retirement savings with a generous company match of 5%

• 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

Our location in Abbott Park, IL currently has an opportunity for a Senior Validation Quality Engineer

The Opportunity

The Senior Quality Engineer will function as the regional SME providing Validation support, consultation, and training to Abbott Nutrition (AN) manufacturing sites. This position will also interface with other regional SMEs to capture and share best practices globally.

WHAT YOU’LL DO

Primary Job Functions:

• Lead global community of practice meetings to exchange best practices.

• Develop and track validation related metrics.

• Provide validation training and consultation services on validation policies and practices.

• Work closely with regional engineering and site quality personnel providing expertise and guidance for verifying and validating new products and processes.

• Collaborate on the definition of the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.

• Assess validation documentation from DQ through protocol execution from a technical and quality perspective, provide feedback and coaching to improve division-wide validation execution, and escalate potential gaps to leadership

• Provide risk management training and facilitation for FMEA development sessions.

• Review, analyze and provide recommendations for verification and validation test data, including sampling strategy and statistical analysis

• Provide guidance on resolving deviations associated with verification and validation activities.

• Collaborate on quality system owner functions such as procedure and template writing and continuous improvement updates and global CAPA impact assessment at the division and site level

• Attend site and project VRBs to support validation strategy development, protocol review, and provide coaching and feedback to VRB members.

What You’ll Work On

• Lead regional community of practice meetings to exchange best practices.

• Develop and track validation related metrics.

• Provide validation training and consultation services on validation policies and practices.

• Work closely with regional engineering and quality personnel providing expertise and guidance for verifying and validating new products and processes.

• Provide guidance on change impact assessment and associated deliverable requirements for changes to systems under change control.

• Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.

• Review, analyze and provide recommendations for verification and validation test data.

• Provide guidance on resolving deviations associated with verification and validation activities.

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required:

• Bachelor’s Degree in engineering, science, or technical related field.

• Engineering degree is preferred

Preferred:

• 5 years or more experience of experience in design/process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.

Apply Now (https://www.jobs.abbott/us/en)

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $83,000.00 – $166,000.00. In specific locations, the pay range may vary from the range posted.

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 corpjat@abbott.com