Validation Engineer – Regulated Manufacturing & Training

Abbott; Sturgis (MI); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

Training and career development

Medical Benefits start day 1

Robust 401(k) retirement savings witha

Tuition reimbursement, the Freedom 2

Job summary

Abbott Nutrition in Sturgis, MI seeks a Validation Engineer to lead and maintain a compliant site validation program across regulatory quality requirements. This role supports product transfers, process improvements, capital projects and validation-related initiatives, acting as a key SME to guide internal stakeholders.

You’ll manage validation documentation and workflows, provide training, oversee master plans and remediation of gaps, and ensure audits and regulatory expectations are met across

Qualifications

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

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, 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.

Education

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

Job description

Abbott Nutrition in Sturgis, MI seeks a Validation Engineer to lead and maintain a compliant site validation program across regulatory quality requirements. This role supports product transfers, process improvements, capital projects and validation-related initiatives, acting as a key SME to guide internal stakeholders.

You’ll manage validation documentation and workflows, provide training, oversee master plans and remediation of gaps, and ensure audits and regulatory expectations are met across