Role Objective:

The design, development, and regulatory compliance of robust primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmics, Injectables, and Drug-Device Combination Products across USV sites and CDMOs. This role ensures seamless launch execution, cost optimization, vendor qualification, and full compliance with global regulatory standards (ISO/USP)

KEY RESPONSIBILITIES

- Design & Innovation: Design and develop primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmics, Injectables, and Drug-Device Combination Products (including Pen Injectors and Autoinjectors). Introduce new packaging concepts, technologies, and continuous improvements for new or existing product categories.
- Regulatory Compliance & Technical Documentation: Prepare and review technical documentation for regulated markets, including Threshold Analysis Reports, Design History Files , Device Master Records , Device History Records , and Medical Device Reporting (MDR) for 510(k) submissions. Prepare technical responses for regulatory queries and briefing packages.
- Process Optimization & Commercial Execution: Prepare and review Specifications, STPs, MPCs, BOMs, and BPRs for submission and commercial launch batches at USV sites and CDMO/CMO facilities. Oversee packaging activities for submission/launch batches, evaluate packaging line machinery compatibility, lead blister change-part development, conduct equipment trials (FAT/SAT), and optimize line processes.
- Value Engineering & Risk Management: Identify, evaluate, and implement continuous cost-optimization and value-engineering projects across packaging formats. Lead Risk Management activities, Failure Mode and Effects Analysis (FMEA), and Human Factors Equivalency studies.
- Testing & Characterization: Execute functionality and physical performance testing for solid oral packaging and drug-device combinations. Perform Reference Listed Drug (RLD) / Innovator packaging characterization, trade dress development, and reverse engineering.




- Vendor & Systems Management: Lead packaging material and device supplier development and vendor qualification activities. Maintain hands-on operational management using SAP and TrackWise systems.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

- Interaction with: Cross-Functional Teams (CFTs) including R&D;, Quality Assurance, Regulatory Affairs, Production, Supply Chain, and Commercial Operations across USV sites
- Nature of Interaction: Technical review, project tracking, regulatory query response compilation, packaging line trials, and seamless transfer of packaging technologies to production.

Type of Interaction: External

- Interaction with: Contract Development / Manufacturing Organizations (CDMO/CMO counterparts), packaging material suppliers, device vendors, and equipment manufacturers.
- Nature of Interaction: Vendor qualification, equipment trials (FAT/SAT), technical discussions on change-parts, component sourcing, value engineering initiatives, and batch execution tracking.

JOB REQUIREMENTS Qualified Experience and Relevant Skills

Experience: 8 to 10 years of post-qualification experience in Pharmaceutical & Medical Device Packaging Development.

Technical Expertise:

- Deep technical expertise in solid orals, injectables, ophthalmics, and drug-device combination products (Pen Injectors/Autoinjectors).
- Thorough knowledge of global packaging standards (ISO 11608, ISO 11040, ISO 13485, ISO 14971)
- Hands-on knowledge of blister & bottle packing machines, change-part development, FAT/SAT equipment trials, and line optimization.
- Proficiency in generating DHF, DMR, DHR, FMEA, and 510(k) submission documentation.
- Hands-on working knowledge of SAP and TrackWise tools.

Skills: Strong cross-functional collaboration, project management, technical writing, problem-solving, and vendor negotiation skills. Academic Qualifications & Certifications:

- Educational Qualification: Post Graduate Degree or Diploma in Packaging Technology from the Indian Institute of Packaging (IIP) or SIES Institute of Packaging.

📌 R&D Packaging Development (Mumbai)
🏢 USV
📍 Mumbai