Validation Engineer - Regulated Medical Devices (GxP)

Abbott; United States; On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

Training and career development

Health care and well-being programs

Vacation and holidays

Robust 401(k) retirement savings

Tuition reimbursement

Employer-sponsored benefits

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Education

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

Tools

M-Files

Job description

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.