Packaging Development Engineer

Job Title: Packaging Development Engineer

• Location: Morristown, NJ
  
  
  

About The Job

About Sanofi:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities

• Provide both technical expertise and technical project management support needed for new product implementations (CMC) and life cycle management changes (LCM) packaging projects in the perimeter of GDPU.
• Development of technical positions regarding packaging material and component performance and Regulatory compliance for Sanofi packaging practices. This includes investigating and recommending new packaging materials, systems, and technology for potential use in Sanofi packaging systems considering the 3Ps (Patient, Planet and Performance)
• Support activities within GDPU regarding technical documentation, SOPs, and internal systems.
• Support multi-functional teams to formulate plans and strategy that meets the defined objective.
• Collaborate with R&D Drug Development, iCMC, IA packaging sites, component and material suppliers, Regional Marketing, Regulatory, Supply Chain, Procurement, Engineering and QA in the development of project strategies and objectives.
• Makes technical and business-based recommendations on primary (for solids form), secondary and tertiary package systems, and material for both new and marketed pharmaceutical product projects.
• Develops test protocols and manages execution of various packaging studies including material tests and transport qualification for finished drug product and packaging.
• Acts as technical focal point for site, CMO or platform driven projects regarding technical documentation of package requirements. Define development actives and develop sub project plans that meet the defined objectives. For new packaging platform projects, acts as project manager to plan and manage all technical packaging requirements for successful introduction of packages from development stages to commercial market.
• Identifies new packaging technologies and/or applications that could improve cost, compliance, sustainability, quality and/or customer acceptance.
• Represents PSA Department in the development, qualification, dossier preparation and launch of new products. Participate as an active member on: Project teams, Tech Transfer Teams, Launch Teams, and Packaging Task Forces.
  
  
  

About You

Basic Qualifications

• 7 years of experience in pharmaceutical packaging development, project management, manufacturing operations or other related fields.
• Bachelors degree in Engineering, material science, life sciences or related fields
• Demonstrates comprehensive knowledge of solid primary secondary and tertiary packaging material types and their technical performance characteristics, cost, and manufacturing processes.
• Working knowledge to advanced understanding of principles and applications behind the packaging materials testing and performance requirements defined in USP, ASTM, ISTA, IATA, CFR, and FDA Guidances.
• Solid project management skills with varied scope and complexity with multifunctional/ organizational project teams is preferable.
• Has comprehensive knowledge of the related pharmaceutical customer, supply and distribution requirements and considers their wants/needs into packaging solutions.
• Has knowledge of FDA Regulations regarding required documentation and data to support new product registrations and various types of changes to primary packaging materials.
• Required tools: Project management experience; strong technical writing skills; proficiency with MS Office tools (e.g., responsibilities include authorship of Technical Packaging Reports).
• Excellent English skills - verbal and written (e.g., responsibilities include internal and external interactions with suppliers and customers technical discussions, e-mail, presentations, etc.).
• Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
• Experience in packaging equipment start-up, qualification and validation is preferable
  
  
  

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
  
  
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.