Manager - Packaging Technology

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Division

Piramal Critical Care

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.  

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.  

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs. 

For more details, please visit https://www.piramalcriticalcare.com/global/ 

Job Title

Manager - Packaging Technology

Job Description

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.

•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.

Bachelor of Science (BSc)