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Job Description

About the Role:

The Manufacturing Investigation, Sr Manufacturing Support Specialist is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and reporting on deviations and defects. Sr Manufacturing Support Specialist will initiate and execute deviations in support of Manufacturing. Also, he/she will lead the deviation team mentoring junior lead investigators and contributing to the department strategy.  Additionally, Sr Manufacturing Support Specialist will lead L1 Change Controls to implement process changes and improvements. The incumbent provides technical support to the manufacturing functions which includes filling, inspection, and packaging operations. By maintaining high-quality standards, this role supports Takeda's mission to deliver better health to people and a brighter future to the world.

How you will Contribute:

• Conduct and document Investigation in a timely manner to support the on-time closure of non-conformances to meet product fulfillment dates.
• Lead L1 Change Controls to implement process changes and improvements.
• Support problem solving sessions through application of the problem-solving tools and methods to coordinate and/or lead investigation teams. Lead routine and complex investigations.
• Lead complex investigations with multifunctional teams and other manufacturing sites.
• Define and specify activities, processes, and standards to meet quality requirements
• Audit and monitor processes to ensure compliance with internal and regulatory standards
• Conduct product integrity testing, including coloring, fitting, pattern, and wet processing
• Report on process deviations and defects, recommending corrective actions
• Manage projects and processes independently with limited supervision
• Coach and review the work of lower-level professionals
• Apply advanced knowledge to solve difficult and sometimes complex problems.
• Mentor junior Lead Investigators and contribute to the department strategy

What you bring to Takeda:

• High School Diploma or GED plus 5+ years of related experience OR Bachelors' degree in science, engineering or other related technical field and 2+ years of related experience.  Technical writing experience preferred.
• Applies basic investigation techniques in straightforward situations with guidance.
• Identifies basic flaws using Corrective And Preventive Action principles, learning to apply corrective measures with guidance.
• Utilizes root cause analysis in simple situations with ongoing supervision.
• Applies basic principles of Good Manufacturing Practices with guidance.
• Understands and applies basic concepts of Quality Assurance with guidance in routine situations.
• Applies basic auditing concepts in simple situations with ongoing supervision.
• Develops practical writing skills, requiring supervision and feedback on basic grammar and punctuation.
• Understands and applies basic safety concepts under close supervision.
• Applies basic quality control principles in routine situations with some coaching.
• Performs simple tasks in biotechnology with supervision, understanding basic biological processes.
• Understands fundamental concepts of process improvement, requiring ongoing supervision.
• Develops verbal communication skills, needing coaching to convey messages clearly in familiar contexts.

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.

More about us:

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.

#GMSGQ  #ZR1  #LI-Onsite

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

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