Job Description

Business

: Piramal Critical Care

Department

: Packaging Development

Location

: Hyderabad

Travel

: Low

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

Reporting Structure:

Role reports to: Chief Manager Packaging Technology

Experience

Bachelor's 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.

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. 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.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.



We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.


PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.


Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.


Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.