Packaging Development Engineer

Job Title

Packaging Development Engineer

Morristown, NJ

Sanofi delivers 4.3 billion healthcare solutions every year, thanks to meticulous planning and eye for detail.

• Provide technical expertise and project management support for new product implementations (CMC) and life cycle management changes (LCM) packaging projects in GDPU.
• Develop technical positions regarding packaging material and component performance and regulatory compliance.
• Investigate and recommend new packaging materials, systems, and technologies considering 3
  
  Ps (Patient, Planet, Performance).
• Support technical documentation, SOPs, and internal systems.
• Collaborate with R&D, iCMC, IA packaging sites, suppliers, marketing, regulatory, supply chain, procurement, engineering and QA to develop project strategies.
• Makes technical and business recommendations on primary, secondary, tertiary package systems and materials for new and marketed products.
• Develop test protocols and manage execution of packaging studies including material tests and transport qualification.
• Act as technical focal point for site, CMO or platform projects regarding technical documentation of package requirements.
• Define development activities and sub‑project plans.
• Act as project manager for new packaging platform projects to manage all technical requirements from development to commercial market.
• Identify new packaging technologies and applications that can improve cost, compliance, sustainability, quality and customer acceptance.
• Represent PSA Department in qualification, dossier preparation and launch of new products.
• Participate as member of project teams, tech transfer teams, launch teams and packaging task forces.

• 7+ years of experience in pharmaceutical packaging development, project management, manufacturing operations or related fields.
• Bachelor’s degree in Engineering, material science, life sciences or related fields.
• Comprehensive knowledge of solid primary, secondary and tertiary packaging material types, performance characteristics, cost, and manufacturing processes.
• Strong understanding of testing and performance requirements defined in USP, ASTM, ISTA, IATA, CFR, and FDA Guidance.
• Solid project management skills with varied scope and multifunctional teams.
• Knowledge of customer, supply and distribution requirements to tailor packaging solutions.
• Knowledge of FDA regulations related to documentation and data for new product registrations and packaging changes.
• Project management experience; strong technical writing skills; proficiency with MS Office tools.
• Excellent English verbal and written communication skills.
• Ability to work cross‑functional, strong analytical and troubleshooting skills.
• Experience with packaging equipment start‑up, qualification and validation (preferable).

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 protected characteristics.