Project Engineer, Product Transfer

Overview

Project Engineer, Product Transfer supports implementation of process improvements for Supplier Initiated Change Request procedures and manages SICR-related electronic systems and supplier coordination.

What you'll do

• Support process improvements for Corporate/Site/Division Supplier Initiated Change Request procedures.
• Own, execute, and maintain electronic systems for SICRs.
• Ensure data alignment between SICR Database and OnePLM SICR Library.
• Review and challenge supplier SICR forms for completeness and accuracy, and discuss corrections.
• Review submitted SICRs, ensure missing information/deliverables are identified, and drive approval readiness.
• Organize SCRB with key stakeholders and obtain buy-in on the type of change.
• Execute ECR/ECNs and promotion requests in OnePLM for change approval.

What you'll need

• Honors Bachelor’s degree in Engineering or Science (or equivalency).
• 3+ years of experience in a manufacturing environment (or equivalent).
• Basic knowledge of GMP, ISO 13485, and 21 CFR Part 820 standards.
• Good communication skills.
• Willingness to travel to different geographical locations to support business needs.
• Knowledge of continuous improvement methodologies.
• Hands-on experience with PPAP, MSA, and creation/review/approval of documentation from suppliers.
• Hands-on experience of validation activities (IQ, OQ, PQ).

Details

• Work flexibility: Hybrid.
• Travel percentage: 10%.