AstraZeneca Pharmaceuticals LP Senior Packaging Technologist in West Chester, Ohio
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The Senior Packaging Technologist will have overall accountability for delivering packaging design and related qualification for new packaging materials or designs including product, quality, regulatory and machinability requirements. Supports technology transfers as it relates to packaging and improvement initiatives as the technical expert for packaging materials and acts as the first line of support for all project related work. Responsible for maintaining a strong relationship with global teams (GTO, PT&D, global packaging, global labelling group etc.), Quality, as well as, collaborating within the PET/Facility and with other packaging and process engineers.
Establishment, improvement, validation, ownership and management of technical specification of packaging components including but not limited to:
Adaptation of site specific requirements from global standards to develop packaging specifications for all new packaging components
Generation of component drawings, technical layouts
Approval of all artwork, technical layouts, and BOMs
Collaborating with global teams on Packaging Configuration Validation requirements, resulting in authoring and executing protocol.
Support to regulatory teams for packaging and labeling information required for submissions
Support technical transfers and new product launches for initial markets during NPI phase and successful transfer of support to PET for LCM phase of a new product
Ensure all packaging design meets local market regulatory requirements (i.e. e-coding, tamper evidence etc.)
Understanding of variability, using analysis, data acquisition and application of improvement to maintain controlled state of compliant component and equipment interface through process qualification and in the early stages of commercial manufacture
Reactive and proactive technical support, investigation, problem solving and application of continuous improvement and control to packaging components and equipment interface of manufacturing execution
Integrates with key functions i.e. Procurement, supply chain, global packing, GTO/PT&D, and the PET to optimise the component and device interaction of machine material interface associated of packaging equipment, asset and processes
Design, Execution and/or Evaluation of Technical work required supporting a decision and/ or implementing a change.
Project Management for packaging component or equipment related projects
Provide technical advice and information to members of the Packaging Manufacturing Team
Provide manufacturing insight into AZ development of packaging concepts and prototypes
Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the PET/Facility process
Maintain external technical relationships and collaborates with equipment and material suppliers
Perform and maintain appropriate change control and risk management activities for NPIs or new packaging initiatives
Works collaboratively within NPI teams, PET Engineers and global colleagues
Key contact for regulatory inspections as technical process owner
BS in Engineering, or related science
Experience in GMP or regulated production environment
Experience in packaging development related to new products, including development of packaging design, technical transfer, process and packaging configuration validation
Advanced technical degree or professional certification related to packaging
Uses their insight to challenge and adapt current approaches/ways of doing things
Experience in Six Sigma/ analytical trouble shooting skills
Experience working in a LEAN manufacturing environment
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.