Senior Packaging Process Engineer

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda''s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role: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.How you will contribute: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:Packaging EquipmentCharacterize primary, secondary and tertiary packaging components o Selection, testing and maintenance of packaging equipmentCombination Product and Device PackagingPackaging & Art-Work SpecificationsPackaging Process Development and OptimizationNew Technology Acquisition or New Package IntroductionSerialization ISO 15415 - Barcode Verification o Identification and qualification of alternate sources for packaging componentsAuthor 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:Provide technical support to quality, manufacturing/packaging operations, supplier relations management and pharmaceutical sciences/process development.Manage multiple responsibilities to support department and sites, such as Change Requests, Non-conformance/CAPA, department projects, learning activities and several operational improvement programs.Lead and conduct complex technical investigations: author and approve technical documentation, including SOPs, Validation Master Plans and Technical Reports.Troubleshoot components and equipment issues to resolve packaging complaints, investigation and deviations.Provide technical perspective during internal and external audits, regulatory inspections and due diligence.Be the Package Engineer to the Product Technical Teams or Site Support in ensuring safe supply of commercialized product.What you bring to Takeda: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:Marchesini Packaging EquipmentSystech and Cognex Camera SystemMarkem, Wolke and Zebra Printers.What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportProfessional development opportunitiesTuition reimbursementImportant ConsiderationsAt 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: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 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.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 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.GMSGQZR1LI-MA1EEO StatementTakeda 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.LocationsUSA - GA - Social Circle - Hwy 278Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Created: 2025-07-12