Sr Process Engineer

Posted Yesterday
Be an Early Applicant
Brooklyn Park, MN, USA
Hybrid
90K-141K Annually
Senior level
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Serves as the engineering subject matter expert for pharmaceutical manufacturing process systems, overseeing lifecycle management, qualification, reliability, modifications, troubleshooting, and regulatory compliance. Develops engineering specifications, commissioning and validation protocols, maintenance plans, and corrective actions. Supports capital projects, capacity planning, production operations, and facility uptime while partnering cross-functionally. The role requires pharmaceutical or biotechnology manufacturing experience, knowledge of cGMP and FDA-regulated environments, and participation in a 24/7 on-call rotation.
Summary Generated by Built In

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 utilities systems)

Ensure systems remain in a qualified state. Act as technical owner for system lifecycle including design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning

Monitor system reliability and performance. Develop and implement engineering solutions to complex problems. Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices. Support development of site staff on technical and procedural topics

How you will contribute:
  • Develop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications
  • Implement system modifications under cGMP change control
  • Develop and execute FAT, commissioning protocols, and qualification protocols
  • Develop calibration and preventative maintenance plans
  • Lead deviation investigations and implement corrective and preventative actions
  • Participate in capital planning, spending, and tracking
  • Serve as project manager on small to medium projects under $5M
  • Interface with cross-functional teams to meet project goals
  • Stay current with industry best practices and technologies
  • Complete required training within timeframe
  • Selecting technologies, designing equipment, and diagnosing process issues
  • Making data-driven decisions using engineering principles
  • Ensuring impact to product quality, safety, reliability, and throughput
  • Maintaining regulatory compliance and validation requirements
  • Troubleshooting factory floor issues and supporting capacity planning
  • Managing impact to uptime, batch continuity, and manufacturing schedule
  • Responding to urgency and severity of equipment failures
  • Determining escalation thresholds
  • Balancing short-term mitigation versus long-term solutions
  • Perform other duties as assigned
What you bring to Takeda:
  • Bachelor’s degree in Engineering
  • 3 or more years of relevant experience
  • Experience in pharmaceutical or biotechnology manufacturing environment
  • Engineer-in-Training (EIT) or Professional Engineer license preferred
  • Demonstrated track record supporting process operations and projects in an FDA-regulated environment
  • Knowledge of engineering principles including fluid mechanics, heat transfer, thermodynamics, and mass transfer
  • Experience applying project management methodologies
  • Understanding of commissioning and qualification protocol development
  • Direct experience with systems such as bioreactors, centrifugation, chromatography, tangential flow filtration, CIP, autoclaves, clean utilities, and HVAC
  • Familiarity with instrumentation and sensing technologies in pharmaceutical manufacturing
  • Experience with regulatory requirements and GMP environments
  • Experience supporting large capital projects
  • Familiarity with batch control systems, data historians, SQL, and scripting (preferred)
  • Knowledge of automation, PLCs, power systems, and controls (desirable)
  • Proficient in MS Office (Word, Excel, PowerPoint) and MS Project
  • Ability to work in fast-paced, cross-functional teams
  • Strong planning, prioritization, and escalation judgment
Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • Combination of sedentary work and facility walkdowns
  • Occasional ladder climbing
  • Ability to lift up to 25 lbs
  • Participation in 24/7 on-call rotation
  • Use of PPE and clean room garments as required
  • Infrequent travel up to approximately 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.

#GMSGQ  #ZR1  #LI-Onsite

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:

$89,900.00 - $141,240.00

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. 


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.

LocationsBrooklyn Park, MN

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

Skills Required

  • Bachelor's degree in Engineering
  • 3 or more years of relevant experience
  • Experience in a pharmaceutical or biotechnology manufacturing environment
  • Experience supporting process operations and projects in an FDA-regulated environment
  • Knowledge of fluid mechanics, heat transfer, thermodynamics, and mass transfer
  • Experience applying project management methodologies
  • Understanding of commissioning and qualification protocol development
  • Direct experience with bioreactors, centrifugation, chromatography, tangential flow filtration, CIP, autoclaves, clean utilities, or HVAC
  • Familiarity with instrumentation and sensing technologies in pharmaceutical manufacturing
  • Experience with regulatory requirements and GMP environments
  • Experience supporting large capital projects
  • Engineer-in-Training or Professional Engineer license
  • Familiarity with batch control systems, data historians, SQL, and scripting
  • Knowledge of automation, PLCs, power systems, and controls
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Microsoft Project
  • Ability to work in fast-paced, cross-functional teams
  • Strong planning, prioritization, and escalation judgment

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

Takeda Insights

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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