USA-Process Engineer III (Engineering)

Support activities within MSAT-US regarding technical documentation, SOP’s, and internal systems. Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for packaging process practices. This includes investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Sanofi packaging and Pharma manufacturing systems.

Duties:

• Provide both technical and project management support as needed for CMC and packaging projects in the perimeter of MSAT in support of late stage NCE development, Life Cycle Management Programs (LCM) and Commercial Products.
• Support multi-functional teams to formulate plans and strategy that meets the defined objectives.
• Collaborate with R&D Drug Development, iCMC, IA packaging sites, component, material and equipment suppliers, Regional Marketing, Regulatory, Supply Chain, and QA in the development of project strategies and objectives.
• Lead or support the qualification (IOQ/PPQ) of process and packaging and primary and secondary equipment
• Lead or support the qualification of transport systems for bulk / intermediates and finished products to established.
• Make technical and business-based recommendations on pharma and packaging processing supporting product development for both new and marketed pharmaceutical product projects.
• Develop test protocols and manage execution of various studies including transport qualification for bulk and finished drug product and packaging finished goods.
• Act as technical and coordination focal point for sites and external CMOs for multi-site projects regarding technical documentation.
• Identify new processes for pharma and packaging technologies and/or applications that could improve cost, compliance, and quality and/or customer acceptance.
• Represent Manufacturing & Supply 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 Force sub teams.
• Support the GDPU and MSAT in evaluations of primary packaging material systems as considerations to individual project objectives.
• Make recommendations for equipment for pharma and packaging processes, new drug product stability programs based on product protection, technical performance, and cost considerations.
  
  

Qualifications:

• Bachelor's Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering and 5 years of experience
• Comprehensive knowledge of solid and liquid oral processes and packaging material types and their technical performance characteristics, cost, and manufacturing processes.
• Working knowledge 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 multi-functional/organizational project teams.
• Knowledge of FDA and EMA Regulations regarding required documentation and data to support new product registrations.
• Required tools: strong project management experience; strong technical writing skills; proficiency with MS Office tools (e.g., responsibilities include authorship of Technical Packaging Reports).
• Soft skills: 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 equipment start-up, qualification, and validation (Process and Packaging).