Process Engineer

Hi,

My name is Karthik Mutyala and I’m 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