The Packaging development manager is responsible to lead and guide a team of packaging engineers on 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 in 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.
- Designing packaging systems / Medical Devices for anesthetic drug products including materials for primary, secondary, and tertiary packaging as well as equipment automation for those processes.
- Support and development for adaptors, integrated closures, kits, and vaporizers
- Development of 3D CAD & SolidWorks models of parts and assemblies along with the creation of engineering drawings for products, components, tooling, etc.
- Lead and guide the team of packaging engineers on various packaging projects and guide them on day-to-day operations including supporting internal & external/CMO packaging lines, packaging components. Optimize products for manufacturability and facilitate the transfer of the design to manufacturing for liquid products. (volatile / nonvolatile).
- 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
- Identification and refinement of design inputs
- Develop usability and human factor test protocols, recruit participants, conduct usability testing, analyze test results, and write formative and summative usability test reports
- Participate in writing verification protocols, testing, analysis, and interpretation of test data
- Management and release of verification reports
- Designing, management, and implementation of product design processes
- Create and maintain the Design History File
- 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.
- Maintain and update manufacturing documents, and assembly instructions
- Perform root cause analysis, provide recommendations, write, implement corrective/preventive actions, verify the effectiveness, and train when necessary
- Create a product priority timeline and coordinate with team members
- Developing, reviewing, and approving the following packaging documents: packaging component specifications, packaging component drawings, design history files (for combination products), risk/criticality assessments, and procedures for bulk and finished drug products.
- Supporting primary packaging-related regulatory filings.
- Ownership of 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.
- Leading and/or participating in harmonization/standardization, quality risk remediation/reduction, and continuous improvement projects.
- Developing, tracking, and maintaining project plans and 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 required.
Mechanical Engineer / Graduate in Packaging Technology with strong medical device development expertise
- Bachelor’s degree with 15-20 years of professional experience in pharmaceutical (sterile product manufacturing is preferred) or medical device industries.
- Experience developing primary container designs and specifications and supporting primary packaging-related regulatory filings.
- Strong leadership and project management skills with a proven track record within Packaging and/or Engineering.
- Experience working in New Drug Product Development is preferred.
- Experience with graphics and labeling of packaging components.
- Solid background in primary packaging components such as glass and plastic containers, rubber closures, seals, and syringes.
- Experience in writing, executing, reporting, and presenting packaging system evaluations.
- Experience in writing technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files)
- Strong understanding of global regulations regarding packaging
- Knowledge of line trial, equipment qualification, and validation practices are required.
- Knowledge of combination products, design controls, and ISTA standards and application to pharma & medical device products.
- Strong medical device regulation knowledge.
- Proficiency utilizing MS Office Suite (Word, PowerPoint, Excel, etc.), AutoCAD, and TOPs/CAPE Pallet Patter programs and knowledge about SAP is preferred