Process Engineer

Stark Pharma; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma is looking for an experienced Tech Transfer Process Engineer to support technology transfer and startup activities in Minneapolis. The role involves process knowledge transfer, operational readiness, and CQV support across pharmaceutical and biologics manufacturing environments.

With an initial onsite schedule of 1 week per month, increasing to 50-60% during project execution, this position requires strong experience in both upstream and downstream operations. Collaboration with Engineering, Manufacturing, and Operations teams is essential.

Qualifications

• 5+ years of experience as a Tech Transfer Process Engineer in pharmaceutical or biologics manufacturing.
• Hands-on experience with startup and technology transfer.
• Strong understanding of upstream and downstream bioprocessing operations.

Responsibilities

• Support technology transfer activities for pharmaceutical and biologics manufacturing.
• Assist with startup execution and operational readiness activities.
• Provide technical support across upstream and downstream processing operations.

Skills

Tech Transfer Process Engineering

CIP (Clean-in-Place) systems

Bioprocessing Operations

CQV (Commissioning, Qualification, Validation)

Cross-functional communication

Job description

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