Process Engineer

Takeda; Brooklyn Park (MN); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda in Brooklyn Park, MN is seeking an Engineering subject matter expert for designated biopharma process areas (cell culture, harvest, purification, CIP, or clean utilities). You will own the system lifecycle, from design and installation through qualification, maintenance, deviations, and decommissioning, ensuring systems stay qualified and reliable.

You will develop PFDs, P&IDs, specifications, FATs, and qualification protocols; implement changes via cgmp change control; lead CAPAs and

Qualifications

• Bachelor's degree in Engineering is required.
• Chemical Engineering degree is preferred.
• Engineer-in-Training (EIT) or PE license is preferred.
• Experience in FDA-regulated manufacturing with cGMP is preferred.

Responsibilities

• Serve as engineering SME for a chosen process area and own system lifecycle.
• Develop PFDs, P&IDs, System Specifications, and Functional Specifications.
• Implement changes through cGMP change control processes.
• Develop FATs, commissioning, and qualification protocols.
• Create robust calibration and preventive maintenance strategies.
• Lead investigations and CAPAs for deviations.
• Stay current with biopharma industry best practices.
• May serve as Project Manager on small capital projects (<$1M).
• Collaborate with cross-functional teams to execute initiatives.
• Complete required training within timelines.
• Perform other duties as assigned.

Skills

Cross-functional collaboration

Planning & organization

Communication skills

Education

Bachelor's degree in Engineering

Chemical Engineering degree preferred

EIT/PE preferred

FDA-regulated manufacturing experience preferred

Tools

Microsoft Office

Microsoft Project

Job description

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 escalation 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.

Takeda 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

Benefits

For information about our benefits, please click here.

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