PurposeNew Recruitment
Position / Job TitleAsst manager/Dy Manager/Manager : Combination Product Device-Packaging Engineer
DepartmentPackaging Development
Reporting ToGM
LocationThane
Years 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 – New 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 same for machinability.
- Perform machine trials along with production team for implementation
- Evaluate the technical documents (TDS, CoA, Tech drawing, layout, Specification & related documents) for different packaging materials
- Review of all packaging related Documents
- Involving in Shop floor trouble shooting for solution
- Regulatory knowledge & understanding (packaging) for US, EU, Canada, Advance RoW & Row market.
- Preparation of Specification of Primary, Secondary & Tertiary Packaging Materials
- Testing of Primary and Secondary packaging materials as per US & EU Pharmacopoeia
- Conduct transport worthiness trials, Reliability Studies in-house & at external facility
- Having Knowledge in machine and machinability
- Having knowledge on Primary, Secondary & Tertiary packaging materials.
- Documentation skills: Good understanding about MPC, BOM, BPR, Intended BPR & other documents required for plant packing operations.
- Preparation of Specs/STP/Protocol. Preparation of Comparative Analysis
- Work very closely with a cross-functional team e.g. Project Management, Formulation Development, Plant Packing team, Planning, Regulatory, Analytical development, QA, QC, Procurement, SCM, CMO to expedite all packaging-related activities, to meet timelines.
- Technology transfer of all new products to plant Tech Transfer team & plant manufacturing/packing team
- Quick response to deficiency, query & fast implementation of regulatory changes
- Handling AVD projects for packaging material
Key Requirements
- Bachelor's degree in mechanical engineering; Diploma/Certification in Packaging Technology preferred
- 5–10 years of relevant experience in packaging development, preferably in pharmaceutical or combination products
- Hands-on experience with drug–device combination products such as nasal sprays, prefilled syringes, auto-injectors, or similar delivery systems
- Strong understanding of packaging materials, device components, and supplier ecosystems
- Experience in preparation and management of Design History Files (DHF) and technical documentation
- Familiarity with design controls, risk management, and validation processes
- Good communication and stakeholder management skills
Preferred Attributes
- Exposure to regulated markets (US, EU, Canada)
- Ability to work in a fast-paced, cross-functional environment
- Strong problem-solving and analytical mindset
- Good communication skills.
- Positive attitude & proactive approach
- Proactive to complete the activities in advance
Additional Notes
- If required, the candidate should be ready to travel to all plant locations as a work priority as per company policy.
- Responsible to ensure compliance with GMP, Health, Safety and Environment requirement.
