Posted to MedZilla on 5/29/2017

Takeda Pharmaceuticals

US-MN, Sr Process Engineer 1700933-MZ


More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!


  • Serve as the engineering lead for a specific process area (cell culture, harvest, purification, clean-in-place, or clean/facility utilities equipment) ensuring systems remain in a qualified state
  • Act as technical owner for equipment lifecycle. This will include design and installation of equipment, qualification, support of ongoing operations, deviation resolution, maintenance, and decommissioning
  • Responsible for system reliability and performance monitoring
  • Support technology transfers and site improvement projects
  • Program owner related to system qualification, asset management, project execution, and Good Engineering Practices


  • Develop engineering deliverables including: Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications
  • Implement system modifications under cGMP change control
  • Generate 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
  • Develop, evaluate, and implement engineering solutions to complex problems
  • Develop of site staff related to procedural and technical matters.
  • Stay current with biopharmaceutical industry best practices and technologies
  • Requires participation in on-call support rotation with other automation and process engineering personnel
  • Work under general supervision


  • Requires Bachelor of Science degree in Engineering or related field
  • Preferred education is Bachelor or Master Degree in Chemical Engineering
  • 4-12 years as an engineer in a pharmaceutical/biotechnology regulated manufacturing environment.
  • 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
  • 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
  • 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
  • Knowledge of process automation, programmable logic controllers, power systems, and controls highly desirable
  • Ability to plan and prioritize work; knowing when to escalate issues
  • General familiarity with Batch-based control systems and Data Historian systems
  • Preferred Engineer in Training (EIT) or Professional Engineer (PE)
  • Occasional climbing of ladders and lifting (25lbs) may be required
  • Will occasionally work in clean-room environment and wear specialized garments (will require removal of make-up and jewelry)
  • Will occasionally work around chemicals such as alcohol, acids, caustics, buffers and bleach that may require personal protection
  • 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

we are driven to improve people's lives

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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