Biopharma Process Systems Engineer (cGMP)

USA - 3345 Takeda Manufacturing U.S.A., Inc; Brooklyn Park (MN); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda in Brooklyn Park, MN seeks an Engineering subject matter expert to oversee specific biopharma process areas, ensuring systems stay qualified and reliable. You will own the lifecycle from design to decommissioning and drive improvements in qualification, asset management, and CAPA execution.

You will develop critical engineering deliverables, lead FATs and qualification tests, and work with cross-functional teams on capital projects.

Qualifications

• Bachelor's degree in Engineering is required.
• 0+ years of engineering experience with increasing responsibility.
• Experience in pharma/biotech regulated manufacturing is preferred.
• Chemical Engineering degree preferred.
• EIT certification or PE license preferred.
• Experience in FDA-regulated industry with cGMP is preferred.
• Knowledge of core engineering principles (fluid mechanics, heat transfer, thermodynamics, mass transfer).
• Familiarity with bioreactors, centrifugation, chromatography, TFF, CIP, clean utilities, HVAC systems preferred.
• Basic knowledge of process automation, PLCs, instrumentation, and controls is desirable.
• Proficiency with MS Office and MS Project is required.
• Strong planning, organizing, and cross-functional collaboration skills.

Responsibilities

• Serve as Engineering SME for a process area (cell culture, harvest, purification, CIP, or clean/facility utilities).
• Own system lifecycle: design, installation, qualification, production support, deviation resolution, maintenance, decommissioning.
• Develop engineering deliverables: PFDs, P&IDs, system specs, functional specs.
• Lead changes through cGMP change controls and FAT/qualification protocols.
• Lead investigations, CAPAs, and preventive maintenance strategies.
• Partner with cross-functional teams on engineering initiatives.
• Stay current with industry best practices and emerging tech.
• May act as Project Manager on small capital projects (< $1M).
• Complete required training within set timelines.

Skills

Engineering fundamentals

cGMP awareness

Project management

Cross-functional teamwork

Planning & prioritization

Problem solving

Communication

Education

Bachelor's degree in Engineering

Chemical Engineering degree preferred

Tools

PLC programming

Process automation software

Instrumentation

Job description

Takeda in Brooklyn Park, MN seeks an Engineering subject matter expert to oversee specific biopharma process areas, ensuring systems stay qualified and reliable. You will own the lifecycle from design to decommissioning and drive improvements in qualification, asset management, and CAPA execution.

You will develop critical engineering deliverables, lead FATs and qualification tests, and work with cross-functional teams on capital projects.