Process Engineer

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

About the role:

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).

How you will contribute:

• 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.

What you bring to Takeda:

• Bachelor's degree in Engineering is required.
• 0 or more years of engineering or related experience with increasing responsibilities is required.
• 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.
• 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 elevate issues, are required.

Important Considerations:

• In general, the position requires a combination of sedentary work and walking throughout the facility.
• May occasionally climb ladders.
• May be required to lift up to 25lbs.
• Requires participation in 24/7 on-call support rotation with other automation and process engineering personnel.
• May occasionally be required to wear personal protective equipment (PPE) and other clean room garments.
• This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, booties, hair nets and gloves and hearing protection.
• Removal of makeup and jewelry would also be required at times.
• Infrequent travel but may approach 25% during project activities.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Compensation and Benefits Summary:

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Brooklyn Park, MN U.S. Base Salary Range: $71,800.00 - $112,860.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations:

Brooklyn Park, MN

Worker Type:

Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes