PurposeNew Recruitment Position / Job TitleAsst manager/Dy Manager/Manager : Combination Product Device-Packaging EngineerDepartmentPackaging DevelopmentReporting ToGMLocationThaneYears of ExperienceAbout 5-10 years.Drug Device Combinations forNasal / Ophthalmic/ Injectable / MDI / Inhaler/ Auto injector/ Pen Device etc. – all kind of Drug Device combination products – Current development, Existing Product, Life Cycle Management, Plant execution

Role Overview

Technically strong Combination Product Device-Packaging Engineer with a background in Mechanical Engineering and specialized training in packaging. The role involves development and lifecycle management of packaging systems for drug–device combination products such as unit-dose nasal sprays, prefilled syringes, and auto-injectors.
Market: Regulated market, Emerging & ROW market

Key Responsibilities

Lead packaging development activities for combination products, including primary, secondary, and device-related packaging components
Work closely with device and packaging suppliers to evaluate, select,



and qualify components and systems
Develop and maintain Design History Files (DHF) and associated documentation in line with regulatory requirements
Prepare and review technical documentation including specifications, drawings, protocols, and reports
Support design verification and validation activities, including packaging qualification and transportation studies
Collaborate cross-functionally with R&D;, QA, Regulatory Affairs, and external partners
Troubleshoot packaging and device-related issues during development and scale-up
Ensure compliance with global regulatory and quality standards (e.g., USFDA, EU MDR where applicable)
Perform Threshold Analysis – with external agencies & inhouse

Other Responsibilities / Deliverables

Handling all packaging activities related to New Product Launch, Existing packaging changes & AVD projects
Develop change part in co-ordination with machine manufacture and evaluation of the

📌 Manager (Thane)
🏢 Rubicon Research
📍 Thane