Department Specialist II

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Job Description

About the role:

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.

How you will contribute:

• 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.

What you bring to Takeda:

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

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. 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.

More About Us:

Takeda Compensation and Benefits Summary

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt