Department Specialist II

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Fractionation Manufacturing provides technical and operational support for the manufacturing processes involved in plasma fractionation. As a Department Specialist, you will ensure all fractionation operations comply with corporate policies, regulatory requirements (GMP, FDA, EMEA), and safety practices. The specialist works closely with cross-functional teams to ensure efficient, high-quality, and compliant production of plasma-derived products.

• Prepare, maintain, and revise GMP (Good Manufacturing Practice) documentation and manufacturing records, including SOPs and job aids.
• Conduct training sessions for team members on general manufacturing processes and industry best practices.
• Proactively identify and help mitigate environmental, health, and safety (EHS) risks.
• Partner with Quality, Engineering, Maintenance, and Safety teams to drive process improvements and support CAPA implementation.
• Take part in root cause analyses, risk assessments, and continuous improvement initiatives using Lean and DMAIC methodologies.
• Contribute to site activities such as Gemba walks, audits, shutdowns, project implementations, and change control tasks.
• Support Tier board updates, 5S, Standard Work, and Business Excellence programs.
• Facilitate team meetings, training sessions, and cross-shift communication.
• Compile, analyze, and document project data, and develop presentations and supporting materials as needed.
• Ensure compliance with all regulatory requirements and internal standards within the manufacturing process.
• Follow established Quality Assurance protocols to uphold and improve quality standards.
• Standard work hours are 8:00 a.m. to 5:00 p.m., Monday through Friday.

• Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred
• Professional (GMP industry) experience ideal

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:

• 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Willingness to work extended or off-hours as required to meet business needs.
• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.

• Some Clean Room and cool/hot storage conditions.

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.

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