Manager - Packaging Technology

Be the First to Apply Job Description Manager - Packaging TechnologyBusiness: Piramal Critical Care Department: Packaging Technology Location: Hyderabad Travel: MediumJob Description Business: Piramal Critical Care Department: Packaging Technology Location: Hyderabad Travel: Medium Job Overview: The Packaging development engineer will be responsible to work for various packaging projects. He/ She will work with cross functional teams to develop, test, validate, and commercialize package solutions / Medical devices for both new and existing products. He/she will support continuous improvements as well as problem resolution and redesign when required for marketed products. The candidate will work on new product development, preparation of technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files), performance analysis, risk management, and design transfer to manufacturing. Key Stakeholders: Internal: Supply Chain, CMO sites, QA, RA and Manufacturing site colleagues Key Stakeholders: External: Pkg Material suppliers Reporting Structure: Role reports to: Chief Manager Packaging Technology Qualification: BS, Mechanical Engineer / Graduate in Packaging Technology with experience in sterile packaging development along with exposure in Medical device development function. Experience: - Bachelor’s degree with 8-14 years of professional experience in pharmaceutical (sterile product experience is preferred) or medical device industries - Experience in developing primary container designs and specifications and supporting primary packaging related regulatory filings - Project management skills with proven track record within Packaging and/or Engineering - Experience in writing technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files) - Strong understanding of global regulations regarding packaging & medical device regulations. Key Roles/Responsibilities: - Designing packaging systems for the anesthetic and sterile drug products (ampoule, vial and PFS) including primary, secondary, and tertiary packaging components as well as equipment automation for the packaging process. - Handling of CMO sites for the Injectable vertical along with complete documentation support (eMPD , eSPEC). - Development 3D CAD & SolidWorks models of parts and assemblies along with creation of engineering drawings for product, components, tooling, etc. - Coordinate with manufacturing / SCM / Logistic team to understand the challenges/improvement scope. - Leverage 3D printing & additive manufacturing processes for prototyping and low-volume production - Strong experience in component development including and not limited to knowledge of stability studies/machine feasibility study/packaging trials, Regulatory filing, shipping studies and validation. - Selection of components and materials for use in product designs and development.