Validation Engineer - Sturgis, MI Plant

Abbott Laboratories • Sturgis, MI

2d • $50,700 - $101,300 • Onsite

About The Position

The Validation Engineer works at Abbott Nutrition’s Sturgis, Michigan location and leads and maintains a site validation program that meets regulatory, corporate, and quality requirements. The role supports product transfers, process improvements, cost-reduction initiatives, capital projects, and other validation-related work while serving as a validation subject matter expert for site stakeholders.

The position manages validation procedures and documentation, evaluates policy changes and their site impacts, and maintains validation master plans, matrices, periodic reviews, and remediation of validation gaps. It coordinates and delivers training, oversees documentation and electronic workflows through M-Files, leads validation personnel, facilitates Validation Review Board activities, and reviews and approves validation protocols. The role also supports audits and represents the site in validation communities of practice and cross-functional forums. The employee is accountable for compliance with FDA, OSHA, and Abbott policies and procedures.

Requirements

• Bachelor of Science in Engineering; Chemical, Biomedical, Mechanical, Industrial, Electrical, or Manufacturing Engineering is preferred.

Nice To Haves

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

Responsibilities

• 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, providing guidance to internal stakeholders and project teams.
• Review and assess validation-related policy changes and evaluate their impact on the site.
• Coordinate and deliver validation training for employees, approvers, and Validation Review Board members.
• Oversee validation documentation, tracking, approvals, and electronic workflows through M-Files.
• Maintain validation master plans and matrices, conduct periodic reviews, and remediate validation gaps.
• Lead validation personnel, facilitate Validation Review Board activities, and review and approve validation protocols.
• Support internal and external audits and represent the site in validation communities of practice and cross-functional forums.
• Meet compliance standards, including FDA, OSHA, and Abbott policies and procedures.

Benefits

• Medical, dental, and vision coverage; medical benefits start on day one.
• Wellness and occupational health programs.
• 120 hours of accrued vacation in the first year, prorated, plus a vacation buy program, three personal days, and 10 paid holidays.
• Retiree Healthcare program.
• 401(k) retirement savings plan with a company match.
• Tuition assistance and tuition reimbursement.
• Freedom 2 Save student debt program and FreeU education benefit.
• Financial security through competitive compensation and incentives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level