Principal Packaging Technologist
AstraZeneca

Job Info

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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.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca's priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events

What you'll do:

Overall accountability for delivering packaging design and related qualification for new product introductions including product, quality, regulatory and machinability requirements. Leads 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 and so on.), Quality, as well as, collaborating within the PET/Facility and with other PET Engineers. Serves as the single point of contact for all technology transfer and technical issues. Responsible for ensuring site business processes align with global packaging and NPI processes and driving continuous improvement and simplification where appropriate.

• Take the technical lead for delivery of the Packaging Technical Support for all technical transfers required for new product introductions from site selection through to manufacture.
• 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 carrying out protocol.
• Support to regulatory teams for packaging and labelling information required for submissions
• Support 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 (such as e-coding, tamper evidence and so on.)
• 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 such as Procurement, supply chain, global packing, GTO/PT&D, and the PET to optimize 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

Essential for the role:

• BS in Engineering, or related science
• Minimum 4 years of experience in GMP or regulated production environment
• Significant experience in packaging development related to new products, including development of packaging design, technical transfer, process and packaging configuration validation
• Ability to coach and mentor peers

Desirable for the role:

• Advanced technical degree or professional certification
• Experience leading a team of technical personnel
• Project management
• 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

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

Find out more on Social Media:

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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

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