Manager - Packaging Development Piramal Finance

8.0 - 12.0 years

25 - 30 Lacs

Hyderabad

Work from Office

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 NA 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 Bachelors degree with 8-12 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. 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 stabilitystudies/machine feasibility study/packaging trials, Regulatory filing, shipping studies and validation. Selection of components and materials for use in product designs and development. Preparation of the protocols, testing procedures as per ASTM & ISO standards, analysis, and interpretation of test data. Preparation of technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files) Create, improve, and maintain Design Control and Quality Management System procedures in collaboration with Quality and Regulatory. Perform root cause analysis, provide recommendations, write, implement corrective/preventive actions, verify effectiveness and train per requirement. Create product priority timeline and coordination with team members Developing, reviewing, and approving the following packaging documents: packaging component specifications, packaging component drawings, design history files (for combination products), project value stream mapping, and procedures for bulk and finished drug product. Supporting primary packaging related regulatory filings. Exposure on distribution testing, shipping studies, line trials, packaging material qualifications, child resistant requirements, human factor studies and patient centric designs. Identification and validation of secondary and tertiary package materials and suppliers. Project execution for harmonization/standardization, quality risk remediation/reduction, and continuous improvement projects. Developing, tracking, and maintaining project plans allied to budgets for packaging related projects. Originating and developing new packaging projects and initiatives that lead to process improvements & have a significant business impact. Supporting sustainability green packaging initiatives as per organizational requirement

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Packaging Engineer - Finished Products Huquo Consulting

2.0 - 7.0 years

5 - 8 Lacs

Kolkata, Jamshedpur, Goa

Work from Office

- Develop various packaging concepts in coordination with finished products and materials used and ensure compatibility of packaging with manufacturing unit. - Assist all internal teams and perform research on all products and evaluate packing requirements in development phase of all products. - Develop all components and packaging labels. - Expertise to promote optimization and cost savings packaging design & solution. - Responsible for Anticipate any potential packaging failure issues and problem solve packaging test failures. - Responsible for analysing logistics, while creating protective packaging structure to ensure a cost-effective shipping method. - Excellent working knowledge of packaging materials and processes, fabrication techniques, cushioning theory, shock and vibration. - Packaging Engineer should have good understanding of all phases of a product's supply chain and logistics enables the engineer to design a package that is reliable, efficient and appealing throughout the entire cycle. - Well known with Packaging material for zero waste initiative or recycling process. - Well aware from conceptualization to design to development of the best packaging solution for the given product. - Work with Merchants and Sourcing/Product Development to create a strategic sourcing plan for distributing artwork to suppliers for development/approval. - Oversee and manage complete packaging development process, including the creation of packaging designs, prototype development, and performance testing. - Analyse and provide support to all activities to achieve all marketing objectives with respect to product packaging & handling - Responsible for improvement in packaging-related engineering changes to meet customer requirements and improve production efficiency. - Any other assignments related to packaging solutions will be assigned by reporting officer time to time on requirement basis.

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