Equipment Qualification Engineer

Serve as a subject matter expert for qualification and commissioning activities.

Lead all phases of qualification: Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification execution, and close-out.

Ensure alignment with internal validation standards and regulatory expectations.

Partner with cross-functional teams (MS&T, QA, Engineering, Operations, vendors) to ensure seamless execution of qualification deliverables.

Prepare, review, and approve qualification documentation such as plans, protocols, and reports.

Support Computerized System Validation (CSV) where applicable.

Investigate deviations, manage change controls, and oversee corrective/preventive actions related to equipment qualification.

Participate in audit preparation and act as SME during inspections.