Manager - Packaging

Key Stakeholders

• Internal: Supply Chain, R&D, Quality Assurance, Regulatory Affairs, Manufacturing
• External: Vendors, Consultants

Reporting Structure

• Reports to: Chief Manager – Packaging Technology

Relevant Experience

• Bachelor's degree with 10–15 years of experience in the pharmaceutical industry (preferably sterile products) or medical device industry
• Proven experience in:
• Primary container design and specification development
• Supporting primary packaging-related regulatory filings
• Strong project management skills within Packaging and/or Engineering
• Experience writing technical documentation for regulatory files (e.g., FDA 510(k) and CE Mark)
• Deep understanding of global packaging regulations and medical device regulatory requirements

Key Responsibilities

• Design packaging systems and medical devices for anesthetic drug products, including primary, secondary, and tertiary packaging
• Support the development of adaptors, integrated closures, kits, and vaporizers
• Develop 3D CAD models using SolidWorks, including engineering drawings for product components
• Collaborate with Manufacturing, Supply Chain, and Logistics to identify improvement opportunities
• Utilize 3D printing/additive manufacturing for prototyping and low-volume production
• Conduct stability studies, machine feasibility studies, packaging trials, and support regulatory filings
• Prepare usability and human factor test protocols, conduct testing, analyze results, and compile reports
• Maintain Design History Files (DHF) and prepare technical documentation for regulatory submissions
• Develop and improve Design Control and Quality Management System (QMS) procedures
• Conduct root cause analyses (RCA) and implement corrective/preventive actions (CAPA)
• Develop and maintain project plans and manage budgets for packaging projects
• Initiate new packaging projects to drive process improvements and business impact
• Support sustainability and green packaging initiatives in line with organizational goals

Key Competencies

• Strong knowledge of packaging materials, processes, and technologies, including medical devices
• In-depth understanding of industry standards and regulatory guidelines
• Ability to identify and solve packaging design and process issues
• Skilled in managing multiple projects, timelines, and stakeholder communications
• Excellent interpersonal and cross-functional collaboration skills

Qualifications

Essential

• BS in Mechanical Engineering or
• Graduate in Packaging Technology with strong expertise in:
• Medical device development
• R&D product packaging development