Stark Pharma
Minneapolis / Global
Process Engineer
- $80.000 - $100.000
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Minneapolis / Global
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
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
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