Process Engineer

Position Overview

We are seeking an experienced Tech Transfer Process Engineer to support technology transfer and startup activities within a pharmaceutical/biologics manufacturing environment. This role will focus on process knowledge transfer, operational readiness, startup execution, and CQV support across both upstream and downstream manufacturing systems.

Key Responsibilities

• Support technology transfer activities for pharmaceutical and biologics manufacturing processes
• Affiliate with startup execution, process scale-up, and operational readiness activities
• Provide technical support across upstream and downstream processing operations
• Support commissioning, qualification, and validation (CQV) activities for manufacturing systems and equipment
• Collaborate with Engineering, Manufacturing, Validation, and Operations teams during project execution
• Support CIP (Clean-in-Place) systems and related process integration activities
• Affiliate with troubleshooting, process optimization, and startup issue resolution
• Participate in field execution activities and support early construction ramp-up efforts
• Ensure documentation and activities align with GMP and regulatory expectations

Required Qualifications

• 5+ years of experience as a Tech Transfer Process Engineer within pharmaceutical or biologics manufacturing environments
• Hands-on experience supporting startup and technology transfer activities
• Strong understanding of upstream and downstream bioprocessing operations
• Experience supporting CQV (Commissioning, Qualification, and Validation) activities
• Working knowledge of CIP (Clean-in-Place) systems
• Strong cross-functional communication and collaboration skills