Process Engineer

Takeda•Brooklyn Park, MN

10d•$71,800 - $112,860•Onsite

About The Position

Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or clean/facility utilities systems), ensuring systems remain in a qualified state. Act as the technical owner for the system lifecycle, including equipment design and installation, qualification, production support, deviation resolution, maintenance, and decommissioning. Monitor system reliability and performance to ensure operational excellence. Develop, evaluate, and implement engineering solutions to complex technical challenges. Support senior engineers in developing and implementing programs related to system qualification, asset management, project execution, and Good Engineering Practices (GEP).

Requirements

Bachelor's degree in Engineering is required.
0 or more years of engineering or related experience with increasing responsibilities is required.
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) and Microsoft Project is required.
Ability to work effectively in a fast-paced, team-oriented, cross-functional environment is required.
Strong planning, prioritization, and organizational skills, including knowing when to escalate issues, are required.

Nice To Haves

Experience working in a pharmaceutical or biotechnology regulated manufacturing environment is strongly preferred.
A Chemical Engineering degree is preferred.
Engineer-in-Training (EIT) certification or a Professional Engineer (PE) license is preferred.
Experience working in an FDA-regulated industry utilizing current Good Manufacturing Practices (cGMP) is strongly preferred.
Working knowledge of core engineering principles, including fluid mechanics, heat transfer, thermodynamics, and mass transfer, is preferred.
Familiarity with the operation, support, or design of bioreactors, centrifugation, chromatography, tangential flow filtration (TFF), Clean-in-Place (CIP) systems, autoclaves, clean utilities, or HVAC systems is preferred.
Basic knowledge of process automation, programmable logic controllers (PLCs), instrumentation, and controls is highly desirable.

Responsibilities

Develop engineering deliverables including Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), System Specifications, and Functional Specifications.
Implement system modifications through cGMP change control processes.
Develop and execute Factory Acceptance Tests (FAT), commissioning protocols, and qualification protocols.
Develop robust calibration and preventive maintenance strategies.
Lead investigations into system deviations and implement corrective and preventive actions (CAPAs).
Stay current with biopharmaceutical industry best practices and emerging technologies.
May serve as Project Manager on small capital projects (less than $1M).
Partner with cross-functional teams to successfully execute engineering initiatives.
Complete required training within established timelines.
Perform other duties as assigned.