Posted to MedZilla on 5/20/2019

Takeda Pharmaceuticals

US-MN, Sr Process Engineer R0007347-MZ


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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Sr Process Engineer in our Brooklyn Park, Minnesota office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr Process Engineer working on the Engineering team, you will be empowered to act as engineering subject matter expert for a specific process area and serve as technical owner for system lifecycle, and a typical day will include:


  • 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 technical owner for system lifecycle. This will include design and installation of equipment, qualification, production support, deviation resolution, maintenance, and decommissioning
  • Responsible for system reliability and performance monitoring
  • Develop, evaluate, and implement engineering solutions to complex problems
  • Lead development and implementation of programs related to system qualification, asset management, project execution, and Good Engineering Practices
  • Assist in development of site staff related to procedural and technical matters.


  • Develop engineering deliverables including: Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications
  • Implement system modifications under cGMP change control
  • Develop and execute Factory Acceptance Tests (FAT), commissioning protocols, and qualification protocols
  • Develop robust calibration and preventative maintenance plans
  • Lead investigations into system deviations and implement corrective actions and preventative actions
  • Participate and make suggestions for capital planning, spending, and tracking
  • Serve as project manager on small to medium sized projects (<$5M) with general supervision
  • Interface with various roles and departments to accomplish project goals
  • Stay current with biopharmaceutical industry best practices and technologies
  • Requires participation in 24/7 on-call support rotation with other automation and process engineering personnel
  • Work under general supervision


Preferred combination of education and experience

  • Bachelor or Master s Degree in chemical engineering or related engineering discipline with 4 or more years of experience in a technical role in a pharmaceutical/biotechnology regulated manufacturing environment
  • Bachelor or Master s Degree in science related field with 8 or more years of experience in a technical role in a pharmaceutical/biotechnology regulated manufacturing environment


  • Must have a demonstrated track record of successfully supporting process operations and projects in a FDA-regulated manufacturing environment
  • Possess knowledge of core principles in various engineering disciplines including fluid mechanics, heat transfer, thermodynamics, and mass transfer, as well as be experienced applying project management methodology
  • Understanding of requirements for developing commissioning and qualification protocols
  • Direct experience with the operation, support, or design of the following systems: bioreactors, centrifugation, chromatography, tangential flow filtration, Clean-in-Place systems, autoclaves, clean/facility utilities, or HVAC systems
  • Familiarity with a variety of instrumentation and sensing technologies related to pharmaceutical manufacturing
  • Experience with regulatory requirements and working in a GMP environment
  • Record of success in supporting large capital projects
  • General familiarity with Batch-based control systems and Data Historian systems, SQL databases, Scripting languages (VB, etc.) is preferred
  • Knowledge of process automation, programmable logic controllers, power systems, and controls highly desirable
  • Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project
  • Embrace working in a fast-paced, team-oriented, cross-functional environment
  • Ability to plan and prioritize work; knowing when to escalate issues


  • Preferred Engineer in Training (EIT) or Professional Engineer (PE)


  • 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


  • Will occasionally work in clean-room environment and wear specialized garments (will require removal of make-up and jewelry)
  • Must occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs)
  • Infrequent travel, but may approach 25% during project activities


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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Brooklyn Park, MN

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Time Type

Full time

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