About the role:

Under the direction of the Head of Process Engineering, you will provide support for operations and projects for manufacturing at the Rancho and Lawrence Manufacturing Facilities. You will report to the Head of Process Engineering.

How you will contribute:

• Demonstrate engineering practices that support operations while improving functionality.
• Apply engineering principles to the design and implementation of major system modifications, process and capital projects.
• Build engineering tasks, make design recommendations with the area leader and assess results for validity and specifications.
• Support manufacturing issues, investigations, and improvements as it relates to process engineering.
• Provide technical expertise for troubleshooting manufacturing process and equipment problems.
• Determine basic causes, develop recommendations for corrective action, and follow-up to ensure completion of corrective action.
• Responsible for all manufacturing equipment life cycle.
• Recommend techniques to improve existing products/processes to improve production efficiency and to reduce cycle time.
• Investigate new sources for raw materials or processes, analyze customer service problems and design improvement suggestions.
• Lead process improvement projects through implementation, training on new processes and measure systems.
• Run projects, qualify equipment, coordinate contractors, and direct the activities of technicians.
• Report project costs, estimate impacts of design/policy changes, and recommend capital expenditures and production methods with the area leader.
• Organize and present technical and project management overviews.
• Use engineering tools to solve straightforward problems (e.g., FMEA, Process Modeling, Design of Experiments, software development).
• Provide solutions that reflect understanding our goals and cost possible effects.
• Analyze how process changes will affect overall production and the product.
• Ensure CGMPs, SOPs, Company Procedures, and Good Engineering Practices are integrated in all activities.
• Through understanding on Packaging Machines and Aseptic processes, Single- Use Equipment, Filling Machines (Isolator and RAB technology), Capping Machines, Parts Washers, Autoclaves, Lyophilizers, CIP/SIP Systems.
• General knowledge of basic principles in different engineering disciplines.
• Knowledge of cGMP manufacturing and GEP.
• Technical writing skills.

What you bring to Takeda:

• B.S. in Engineering is required – Chemical or Mechanical Engineering.
• Minimum 5 years of related experience (in-house, co-op or acquired outside) in a GMP pharmaceutical environment.

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. You may:

• Able to lift, push, pull and carry up to 25 lbs.
• Combination of sedentary work and walking around observing conditions in the facility.
• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Can work more than 8 hours a day or 40 hours a workweek.
• May participate in process engineering on-call program.
• May require availability outside regular business hours.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

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