Associate Principal Packaging Engineer

Role Summary

Packaging Development Associate Principal Engineer (Design controls / Combination products) based in the Pharmaceutical Technology and Development (PT&D) department. Supports the entire PT&D portfolio, delivering packaging strategies and activities for development projects from Phase 1 to transfer to Commercial Manufacture.

Responsibilities

• Lead the design & development, and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion.
• Develop innovative, creative, and cost-competitive packaging solutions that meet patient needs, sustainability objectives, and quality standards.
• Generate and review regulatory submission documents, plans, protocols, and reports ensuring project objectives are met (Design History File documentation).
• Contribute and support information to the Design transfer team to enable successful packaging transfer to AZ manufacturing operations and/or contract manufacturing sites.
• Ensure work is performed in accordance with safety (SHE), quality, and compliance standards.
• Influence understanding and interpretation of packaging regulations.
• Represent specialist packaging area (SME) on Device Project Teams, providing data (technical, resource & budgetary).
• Understand and influence developments within the industry.
• Contribute to training and development of packaging colleagues by acting as coach/mentor as appropriate.

Qualifications

• Minimum 7 years experience
• BSc/PhD in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering, or Pharmaceutical Sciences with related device/biopharmaceutical experience
• Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USA, Europe)
• Strong technical and scientific skills with experience in developing packaging solutions for parenteral and/or inhalation products
• Strong experience with medical device or combination product commercialization, operations support, and substantial packaging materials/components knowledge
• Lean Six Sigma Green Belt or higher certification with strong problem-solving skills
• Demonstrated ability to manage multiple projects of varying complexity
• Strong operational relationships with customers
• Experience leading cross-disciplinary delivery teams

Skills

• Packaging design, development, and testing for medical devices and combination products
• Regulatory documentation and Design History File management
• Design transfer processes to manufacturing sites
• SHE, quality, and compliance knowledge
• Regulatory interpretation and submission support
• Cross-functional collaboration and mentoring

Education

• Relevant engineering degree (BSc/PhD) in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering, or Pharmaceutical Sciences related to devices/biopharma

Additional Requirements

• In-person work expectation: minimum three days per week in the office; flexible arrangements may apply