Sanofi
PackagingDevelopmentEngineer
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“Packaging Development Engineer at Sanofi. Skills: pharmaceutical packaging development, project management, packaging material, packaging systems, Regulatory compliance, technical documentation, packaging studies, packaging equipment. 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 materi”
What You'll Achieve.
Ensure successful introduction of packages from development stages to commercial market; improve cost, compliance, sustainability, quality and/or customer acceptance
Industry & Context.
analytical skills for troubleshooting and root cause analysis
What They're Looking For.
Must Have
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 Guidance’s, 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 technical writing 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 analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members
Nice to Have
Solid project management skills with varied scope and complexity with multifunctional/ organizational project teams is preferable, Experience in packaging equipment start-up, qualification and validation is preferable
What You'll Do.
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
Investigating and recommending new packaging materials
and technology for potential use in Sanofi packaging systems considering the 3Ps (Patient
Planet and Performance)
Support activities within GDPU regarding technical documentation
Support multi-functional teams to formulate plans and strategy that meets the defined objective
Collaborate with R&D Drug Development
component and material suppliers
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
quality and/or customer acceptance
Represents PSA Department in the development
dossier preparation and launch of new products
Participate as an active member on: Project teams
and Packaging Task Forces
How You'll Work.
Team & Collaboration
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; Ability to work in cross functional teams; Participate as an active member on: Project teams, Tech Transfer Teams, Launch Teams, and Packaging Task Forces
Communication Scope
Excellent English skills - verbal and written; communicate with internal and external team members
Process & Methodology
technical project management, project management, project strategies, project plans, project manager, Project teams
Full Job Description
**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, SOP’s, 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 defi
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