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Job Description

Job Title: Sr Packaging Design Engineer

Location: Thousand Oaks, CA

About the role:

You will be involved in the development, qualification, and implementation of secondary and tertiary packaging components in the scope of product launch and life cycle management. Other responsibilities include assisting or leading in package trial runs, project start-ups, resolving manufacturing issues, supporting continuous improvement projects, and labeling development activities. Also, support change control, non-conformances and CAPA activities working with Quality and Labeling Operations.

This is a fully on site position that reports to the Finishing Operations Senior Manager

How you will contribute:

• Develop and implement packaging concepts, characterizing secondary and tertiary components.

• Select, test, and maintain packaging specifications; author and execute material qualification protocols.

• Collaborate with sites to qualify packaging in equipment and processes, coordinating testing related to package qualification.

• Develop, write, and approve documentation for GMP packaging and labeling activities.

• Consult with purchasing, production, and quality departments to assess costs and feasibility of packaging solutions.

• Provide technical support to quality, manufacturing/packaging operations, and supplier relationship management.

• Assist with department support, including Change Requests, Non-conformance/CAPA, and improvement initiatives.

• Act as Subject Matter Expert in packaging-related projects, ensuring compliance with regulatory standards.

• Prepare packaging sections for regulatory submissions and participate in compliance inspections and audits.

• Serve as technical expert for packaging development, ensuring compliance of artworks and technical profiles with criteria requirements.

What you bring to Takeda:

• Bachelor's degree in science, engineering, or another related technical field.

• At least 5 years of related experience in packaging operations, biopharmaceutical, or highly regulated compliance industry.

• Knowledge of packaging standard (ISTA 2A, ISTA 7D, ISO 11607).

• Experience with packaging development.

• General proficiency in negotiations with departments and vendors to resolve issues

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:

• 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/or 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.

• Able to work more than 8 hours a day or 40 hours per week.

• May require availability outside regular business hours.

• May be assigned to a different shift as needed.

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