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Process Engineer

Stark Pharma Solutions Inc

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 #J-18808-Ljbffr

Vacancy posted 1 day ago
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