Role Objective:
The design, development, and compliance of primary, secondary, and tertiary packaging solutions across Solid Orals, Ophthalmic, Injectable, and Drug-Device Combination Products. Drive cost-optimization, regulatory alignment, and technical execution across internal manufacturing sites and CDMO/CMO partners to ensure seamless product development, submission, and commercial launch.
KEY RESPONSIBILITIES
- Packaging Design & Technology Innovation: Design and develop novel primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmic, Injectable, and Drug-Device Combination Products (including Pen Injectors and Autoinjectors). Evaluate new packaging concepts, emerging technologies, and drive continuous improvement across recent and existing product categories.
- Value Engineering & Vendor Management: Identify, evaluate, and execute continuous cost-optimization and value-engineering projects across packaging formats. Lead packaging material and device supplier development, vendor qualification activities, and vendor management.




- Documentation & Technical Specifications: Prepare and review Specifications and Standard Testing Procedures (STPs) for primary packaging materials. Author and review Master Packaging Cards (MPCs), Bill of Materials (BOMs), and Batch Packaging Records (BPRs) for submission and commercial launch batches across USV sites and CDMO/CMO facilities.
- Device Regulatory Compliance & Technical Dossiers: Ensure full compliance with global ISO and USP regulatory standards (ISO 11608, ISO 11040, ISO 13485, ISO 14971, USP , USP , USP , USP , USP ). Prepare and review technical documentation for regulated markets, including Threshold Analysis Reports, Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and Medical Device Reporting (MDR) for 510(k) submissions.
- Risk Management & Testing Execution: Conduct Risk Management activities, Failure Mode and Effects Analysis (FMEA), and Human Factors Eq

📌 Manager- Packaging Development (Govandi East)
🏢 USV
📍 Govandi East