Process Engineer II

Fully onsite
Mission
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 *** packaging and Pharma manufacturing systems.
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.
Duties & Responsibilities
Makes technical and business-based recommendations on pharma and packaging processing supporting product development for both new and marketed pharmaceutical product projects.
Develops test protocols and manages execution of various studies including transport qualification for bulk and finished drug product and packaging finished goods.
Acts as technical and coordination focal point for sites and external CMOs for multi-site projects regarding technical documentation Define actives and developed project plans that meet the defined objectives. In certain situations, acts as Project Manager to plan and manage all technical activities for successful introduction of products from development stages to commercial market.
Identifies new processes for pharma and packaging technologies and/or applications that could improve cost, compliance, and quality and/or customer acceptance.
Represents 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.
Supports the GDPU and MSAT in evaluations of primary packaging material systems as considerations to individual project objectives.
Makes recommendations for equipment for pharma and packaging processes, new drug product stability programs based on product protection, technical performance, and cost considerations.
Identifies new technologies, processes and/or applications that could improve cost, compliance, and quality and/or customer acceptance which improves industry positioning for ***.
Knowledge, Skills & Competencies/Language
Solid project management skills with varied scope and complexity with multi-functional/organizational project teams.
Demonstrates comprehensive knowledge of solid and liquid oral processes and 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 pharma processes and packaging solutions.
Has 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).

Qualifications
Bachelor's Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering