Validation Engineer — Regulated MedTech Compliance Pro

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

Benefits offered by this job

Health benefits start day 1

Vacation time and holidays

Robust 401(k) retirement plan

Job summary

Abbott Nutrition seeks a Validation Engineer in Sturgis, MI to lead and maintain a compliant site validation program across regulatory and quality requirements. You will guide project teams, manage documentation and training, and support transfers and capital projects.

The role requires a BS in Engineering and experience with IQ/OQ/PQ validation, risk assessments, and regulatory audits. Abbott offers comprehensive health benefits and retirement plans.

Qualifications

• Bachelors of Science in Engineering required; Chemical/Biomedical/Mechanical/Industrial/Electrical or Manufacturing preferred.
• Experience with validation lifecycle activities (IQ/OQ/PQ) and risk assessments.
• Experience supporting regulatory audits and inspections.

Responsibilities

• Lead and maintain a compliant site validation program aligned with regulatory and quality requirements.
• Provide validation support for product transfers, process improvements and capital projects.
• Coordinate validation training for staff and VRB members.
• Oversee validation documentation, approvals, and electronic workflows (M-Files).
• Support internal/external audits and remediation of validation gaps.

Skills

Validation knowledge

GxP compliance

Audits support

Education

Bachelors of Science in Engineering

Tools

M-Files

Job description

Abbott Nutrition seeks a Validation Engineer in Sturgis, MI to lead and maintain a compliant site validation program across regulatory and quality requirements. You will guide project teams, manage documentation and training, and support transfers and capital projects.

The role requires a BS in Engineering and experience with IQ/OQ/PQ validation, risk assessments, and regulatory audits. Abbott offers comprehensive health benefits and retirement plans.