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You will be a team member of the Process Engineering group. Process Engineering ensures that the manufacturing equipment/systems used in the production, storage, testing and distribution of products are fit for purpose observing company standards and industry regulatory requirements. The Packaging Engineer will manage the development, launch and life cycle management of primary, secondary and tertiary packaging components, equipment maintenance and engineering projects. The engineer will also manage Product Serialization under GS1 Standard and Barcode Verification under ISO 15415. The engineer will assess, design, specify and implement packaging projects. They also review and improve existing packaging designs. They work with other departments and packaging suppliers to achieve functional packaging goals The engineer will lead package trial runs, project start-ups (FATs/SATs), resolving manufacturing issues, and in packaging validation efforts. Additionally, you will lead change control, non-conformances and CAPA activities working with Quality and Global Labelling Operations. You will provide support to manufacturing system. The Engineer will implement area and system improvements through strict adherence to Standard Operating Procedures and cGMP’s in a Pharmaceutical Manufacturing facility.
Provide technical expertise in their area of specialization (i.e., Packaging Technology /Equipment, Package Design, Serialization, Product Security, Packaging Process Development & Optimization, etc.).
Equipment Owner and the Execution Lead, for one or more processes in their respective area of specialization, including:
Author and implement user requirement specifications, technical and validation protocols and reports.
Work with sites to qualify packaging equipment and new processes including Factory Acceptance testing and site commissioning activities.
Perform and coordinate with sites for package testing related to package qualification activities.
Write packaging specifications to support all GMP packaging and labeling activities.
Implement/Lead in identification and implementation of projects to improve the quality and efficiency of commercial packaging operations by:
Bachelor’s degree in Engineering discipline required. 5+ years of related experience. Some leadership experience preferred for supervisory roles. The minimum requirement to become a packaging engineer is a bachelor’s degree in engineering, packaging science, or another relevant field. Typically, employers also require previous experience in a similar role.
Must have experience implementing engineering projects, and supporting facility issues, in a FDA-regulated manufacturing environment.
Have knowledge of core principles in several engineering disciplines including manufacturing (i.e. aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design.
Direct experience with manufacturing operations and biotechnology processes is preferred.
Be able to work in a team-based environment.
Knowledge of programmable logic controllers, DCS, instrumentation and controls desirable.
Desire Experience with the following:
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. You may:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.
This posting excludes Colorado applicants.
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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.
USA – GA – Social Circle – Hwy 278
Employee
Regular
Full time