Director, Packaging Engineering & Technology

Position Overview
The Director of Packaging Engineering is a strategic and operational leader responsible for driving the development, qualification, and lifecycle management of all packaging systems across the company's product portfolio. This role oversees packaging design, materials engineering, vendor collaboration, regulatory compliance, and packaging-related technology transfer to manufacturing sites. The Director will lead a team of packaging engineers and collaborate closely with R&D, Quality, Regulatory, Operations, and Supply Chain to ensure packaging solutions are innovative, robust, compliant, and aligned with commercial and clinical strategy.

Key Responsibilities

Leadership & Strategy

• Develop and execute the long-term vision and strategy for packaging engineering to support new product development, commercialization, and continuous improvement initiatives.
• Build, mentor, and manage a high-performing packaging engineering team.
• Partner with cross-functional leadership to align packaging strategy with product, manufacturing, and organizational goals.

Packaging Development

• Lead the design, development, and validation of primary, secondary, and tertiary packaging for clinical and commercial products.
• Own packaging specifications, drawings, test plans, and component qualification activities.
• Drive material selection, sustainability assessments, and cost-optimization efforts while maintaining product protection and regulatory compliance.

Regulatory & Quality Compliance

• Ensure all packaging components meet relevant regulatory requirements (FDA, EMA, ISO, ASTM, etc.) and industry standards.
• Serve as SME for packaging-related content in regulatory submissions, audits, and inspections.
• Oversee risk assessments (e.g., FMEA) and packaging-related CAPA activities.

Manufacturing & Operations Support

• Provide technical oversight for packaging scale-up, equipment qualification, and process validation at internal and external manufacturing sites.
• Troubleshoot packaging-related issues in production and support continuous improvement initiatives.
• Collaborate with Supply Chain to evaluate suppliers, manage component lifecycle, and maintain robust packaging supply continuity.

Innovation & Technology

• Evaluate emerging technologies, materials, and automation solutions to drive innovation in packaging processes and product formats.
• Champion sustainability initiatives and environmentally responsible packaging solutions.

Qualifications

Required

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Science, or related field.
• 10+ years of experience in packaging engineering, with at least 5 years in a leadership role.
• Deep understanding of packaging for regulated products (e.g., pharmaceutical, medical device, combination products, biotech, or similar).
• Proven experience with packaging design, material science, testing, and validation.
• Strong knowledge of regulatory requirements and industry standards (FDA, ISO, ASTM, ISTA, etc.).
• Demonstrated ability to lead cross-functional initiatives and manage complex projects.