Packaging Development Manager (Injectable)

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.

Role & 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.
• 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.

Preferred candidate profile

• Bachelors 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.