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BriefCase

Manager - Packaging Technology Job in Piramal Pharma Ltd

Manager - Packaging Technology

Piramal Pharma Ltd 4+ weeks ago
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Job Summary JOB OVERVIEW: The Packaging development engineer will be responsible to work for various packaging projects. They will work with cross functional teams to develop, test, validate, and commercialize package solutions / Medical devices for both new and existing products. They will also 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, R & D, QA, Regulatory Affairs and Manufacturing KEY STAKEHOLDERS: EXTERNAL Vendors & Consultant REPORTING STRUCTURE: Reports to: Chief Manager Packaging Technology RELEVANT EXPERIENCE: Bachelor s degree with 10-15 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 ROLE & RESPONSIBILITIES: 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 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 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. Preparation of the protocols, testing procedures as per ASTM & ISO standards, analysis, and interpretation of test data. Create and maintain 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. Perform root cause analysis, provide recommendations, write, implement corrective/preventive actions, verify effectiveness and train when necessary. 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), risk/criticality assessments, 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. KEY COMPETENCIES: Knowledge of packaging materials, process and technologies including medical devices. Understanding of industry standards and regulatory guidelines related to packaging. Proficient in identifying issues and developing solutions in packaging design and processes. Ability to manage multiple projects, timelines, and stakeholders effectively.. Should have prior work experience working for pharmaceutical industry. Excellent interpersonal skills for working with cross-functional teams, including R&D, Quality, and production. Qualifications ESSENTIAL QUALIFICATION: BS, Mechanical Engineer / Graduate in Packaging Technology with strong Medical device development expertise & R & D Product Packaging Development
Qualification :
BS, Mechanical Engineer / Graduate in Packaging Technology with strong Medical device development expertise & R & D Product Packaging Development
Experience Required :

10 to 15 Years

Vacancy :

2 - 4 Hires

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