Validation Engineer - Sturgis, MI Plant

1003 Abbott Laboratories; United States; Presencial; USD 51.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Training and career development

Health care and well-being programs

Vacation and holidays

Robust 401(k) retirement savings

Tuition reimbursement

Employer-sponsored benefits

Descripción de la vacante

Abbott in Sturgis, MI, is hiring a Validation Engineer to lead and maintain a compliant site validation program within the Nutrition division. You will support product transfers, process improvements, and capital projects, and oversee validation documentation and training for staff.

The role requires a B.S. in a related engineering field and experience with validation lifecycle activities; familiarity with M-Files and regulatory audits is preferred.

Formación

• Bachelor’s degree in engineering required or equivalent.
• Experience with validation programs in regulated manufacturing environments preferred.
• Familiarity with IQ/OQ/PQ, risk assessments, and change control processes.

Responsabilidades

• Lead and maintain a compliant site validation program.
• Support product transfers, process improvements, and capital projects.
• Coordinate validation training and oversee documentation and electronic workflows.
• Interact with audits and validation communities of practice.
• Review policy changes and assess site impacts.

Educación

Bachelors of Science in Engineering (Chemical, Biomedical, Mechanical, Industrial, Electrical, or Manufacturing Engineering preferred)

Herramientas

M-Files

Descripción del empleo

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION: Job Title Validation Engineer 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.

Benefits

• 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 plan
• 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

This position works out of our Sturgis, MI 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. For over 70 years, Abbott’s Sturgis, Mich., has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working here, you’ll feel part of a family that is dedicated to making a difference and helping others.

What You’ll Work On

• The Validation Engineer is responsible for leading and maintaining a compliant site validation program that meets regulatory and corporate quality requirements, while supporting product transfers, process improvements, capital projects, and validation-related initiatives.
• Manage and maintain a site validation program that complies with regulatory, corporate, and quality requirements.
• Ensure validation procedures align with corporate policies and support ongoing site compliance.
• Provide validation support for product transfers, process improvements, cost-reduction initiatives, and capital projects.
• Serve as a validation subject matter expert, offering guidance to internal stakeholders and project teams.
• Review and assess validation-related policy changes and evaluate site impacts.
• Coordinate and deliver validation training for employees, approvers, and Validation Review Board (VRB) members.
• Oversee validation documentation, tracking, approvals, and electronic workflows through M-Files.
• Maintain validation master plans, matrices, periodic reviews, and remediation of validation gaps.
• Lead validation personnel, facilitate Validation Review Board activities, and review/approve validation protocols.
• Support internal and external audits and represent the site in validation communities of practice and cross-functional forums.

Required Qualifications

• Bachelors of Science in Engineering (Chemical, Biomedical, Mechanical, Industrial, Electrical, or Manufacturing Engineering preferred)

Preferred Qualifications

• Experience with validation programs in a regulated manufacturing environment (medical device, pharmaceutical, or related industry).
• Knowledge of validation lifecycle activities, including IQ/OQ/PQ, risk assessments, and change management.
• Experience with electronic document management systems (e.g., M-Files) and supporting regulatory audits and inspections.

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.

Significant Work Activities

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

The base pay for this position is $50,700.00 – $101,300.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Engineering DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Sturgis : Building 01A ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us: Facebook LinkedIn YouTube Twitter