The Packaging Engineer will support the delivery of science, project and departmental objectives.
Provide packaging support to the PD project teams, CTS, and Global Manufacturing Supply network, to ensure:
• Development requirements to support that qualification, registration, and launch key events are met. Activities include, but are not limited to:
- Recommend primary packaging components
- Complete primary packaging specifications and testing
- Manage/complete stability packaging campaigns
- Complete (generate or review) IND/NDA CTX/MAA Container Closure sections with supporting documentation
• Review of post launch primary packaging changes or stability issues, as needed or requested.
• Cost effective package development.
• Alignment of primary pack component usage through PD, CTS, and GMS with Global Procurement input/support to ensure cost effective solutions (i.e., material selection and process)
• Assessment of new materials, components, and technologies for both technical performance and cost effectiveness.
Support the development of strategies on package development and technology across the PD, NPS, GMS, Commercial, and external interfaces to ensure effective PD Product Development Support:
• Globally harmonized and coordinated strategies for pack development activities
• Packaging input to lean manufacture/packaging
• Providing competitive advantage through packaging
• Industry and global developments in packaging, and their adoption to support NPS
• Assessment of external partnering and collaborations
• Support the development and execution of Global Manufacturing Supply Procurement strategies and sourcing groups
Support the development of regulatory, quality, and legislative strategies for packaging to ensure cost effective development:
• CMC regulatory strategy on packaging, especially the primary packaging
• Guidance and cross project support to Regulatory, Quality, and GMS
• Input into Group Quality Policies
• Environmental policy and strategy
• Is personally responsible for using safe working practices and maintaining a safe working area.
• B.S./M.S. degree in Packaging Engineering/Packaging Science, Chemistry, Life Science, or equivalent industry experience, with minimum 1 year experience in package development, primarily in pharmaceutical industry.
• Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, NPS, and technology transfer processes.
• Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
• Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.
• Working knowledge of packaging materials, components, vendors, equipment, legislation, regulations, and technologies and the ability to apply this knowledge to satisfy project goals within PD and GMS.
• Demonstrated knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
SRG Woolf is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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