Process Engineer

Hi

My name is Karthik Mutyala and Im a Recruitment Manager with Stark Pharma specializing in pharmaceutical biotechnology and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.

If interested please send me your updated resume along with the best number and time to reach you.

Job Title: Tech Transfer Process Engineer

Location: Minneapolis MN (Hybrid)

Schedule: Initially 1 week/month onsite increasing to 50 60% onsite during project execution

Contract Duration: 12 Months

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.

The engineer will join during the late design phase and play a key role in transitioning systems into execution commissioning qualification and startup activities while supporting manufacturing readiness and field operations.

Key Responsibilities

• Support technology transfer activities for pharmaceutical and biologics manufacturing processes
• Assist 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
• Assist 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