Packaging Development Engineer

Sanofi•Morristown, NJ

4d•Onsite

About The Position

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 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.

Requirements

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.
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.
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.
Communicate with internal and external team members.
Experience in packaging equipment start-up, qualification and validation is preferable.

Nice To Haves

Solid project management skills with varied scope and complexity with multifunctional/ organizational project teams.
Experience in packaging equipment start-up, qualification and validation.

Responsibilities

Provide technical expertise and project management support for new product implementations (CMC) and life cycle management changes (LCM) packaging projects.
Develop technical positions on packaging material and component performance and regulatory compliance.
Investigate and recommend new packaging materials, systems, and technology.
Support technical documentation, SOPs, and internal systems within GDPU.
Support multi-functional teams in formulating plans and strategies.
Collaborate with various departments and suppliers on project strategies and objectives.
Make technical and business-based recommendations on primary, secondary, and tertiary package systems and materials.
Develop test protocols and manage execution of packaging studies, including material tests and transport qualification.
Act as a technical focal point for site, CMO, or platform-driven projects regarding technical documentation of package requirements.
Define development activities and develop sub-project plans.
Act as project manager for new packaging platform projects, managing technical packaging requirements from development to commercialization.
Identify new packaging technologies or applications to improve cost, compliance, sustainability, quality, and customer acceptance.
Represent the 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.