Validation Engineer - Sturgis, MI Plant

Abbott (abbottcareers2 board); United States; On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Tuition reimbursement

401(k) retirement match

Vacation 120 hours + 3 personal days +

Tuition assistance

Job summary

Abbott is seeking a Validation Engineer to lead and maintain a compliant site validation program at the Sturgis, MI location within Abbott Nutrition. The role supports product transfers, process improvements, capital projects, and validation initiatives across site operations.

You will serve as a validation SME, guiding internal stakeholders, managing documentation and workflows, and ensuring training, oversight, and ongoing compliance with FDA, OSHA, and Abbott policies.

Qualifications

• Bachelor of Science in Engineering (preferred)
• Experience with validation programs in regulated manufacturing environments
• Knowledge of IQ/OQ/PQ, risk assessments and change management

Responsibilities

• Lead and maintain a compliant site validation program meeting regulatory and corporate quality requirements.
• Support product transfers, process improvements, capital projects, and validation initiatives.
• Provide guidance to internal stakeholders and manage validation documentation and workflows.
• Coordinate validation training for employees and VRB members.
• Oversee validation documentation, approvals, and electronic workflows through M-Files.
• Maintain validation master plans, matrices, and remediation of gaps.

Skills

Attention to detail

Project leadership

Communication

Regulatory knowledge

Team management

Education

Bachelor of Science in Engineering

Tools

M-Files

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 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. 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 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. This role serves as a key validation subject matter expert, providing guidance to internal stakeholders, managing validation documentation and workflows, and ensuring effective training, oversight, and continuous compliance across site operations.

• 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.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

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 empl