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Job Description

About the Role:

Join Takeda as an Engineer I where you will provide process support to the Fractionation manufacturing group by investigating and troubleshooting technical issues within the Social Circle Fractionation manufacturing facility. You will assist your quality and manufacturing partners in maintaining process compliance, aiding in the implementation of yield and process improvements, and supporting process validation activities. As part of the Fractionation Manufacturing Sciences team, you will report to the Associate Director of Manufacturing Sciences, Fractionation.

How you will Contribute:

• Troubleshoot and provide timely resolution to technical issues in support of ramp-up and steady-state operations of pharmaceutical manufacturing facilities.

• Ability to solve routine design and engineering tasks with some assistance. Select sound techniques to solve problems and make design recommendations under direction of manager.

• Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.

• Evaluate and prepare product impact assessments for process exceptions.

• Act with supervision to conduct smaller yield and cycle time improvement projects.

• Work with Manufacturing to help promote key metrics such as yields and capacity.

• Track and trend yields and report on the key metrics.

• Work to execute experiments in the Manufacturing Sciences lab.

• Support teams to resolve complex problems.

• Contribute to process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study, etc). Coordinates and supports training and execution of validation activities.

• Promote the use of DMAIC tools in problem solving and projects.

• Analyze scientific, and statistical data to draw appropriate conclusions.

• Actively support information sharing and learning between team members.

• Provide technical support for equipment in manufacturing, as second level support. Gain knowledge of systems to grow into a Subject Matter Expert (SME) role.

What you bring to Takeda:

• Typically requires bachelor’s degree in an Engineering or other related technical field.

• Knowledge of FDA-regulated manufacturing environments is desired/preferred.

• Practical and theoretical knowledge of the purification of plasma proteins and biochemistry.

• Experience with basic engineering principles in various scientific disciplines.

• Ability to solve routine technical problems without assistance.

• Ability to discuss normally encountered technical and project management issues, both verbally and in written form.

• Must have excellent organizational, verbal and written communication skills. Able to efficiently communicate with cross-functional teams and management.

• Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.

• Must be a self-starter and detail oriented. Must be willing to learn and develop engineering and project skills.

• Must embrace working in a fast-paced, team-oriented, cross-functional environment.

• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint). Experience with Minitab or other statistical software preferred.

• Ability to participate in small teams and work as a collabor