Validation Engineer: Regulated Medical Devices

Abbott (abbottcareers2 board); United States; Vor Ort; USD 95.000 - 130.000; Vollzeit

Benefits dieser Stelle

Tuition reimbursement

401(k) retirement match

Vacation 120 hours + 3 personal days +

Tuition assistance

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

Attention to detail

Project leadership

Communication

Regulatory knowledge

Team management

Ausbildung

Bachelor of Science in Engineering

Tools

M-Files

Jobbeschreibung

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.