Associate Principal Packaging Engineer

AstraZeneca • Durham, NC

82d

About The Position

We have an open position for a Packaging Development Associate Principal Engineer (Design controls / Combination products) based in our Pharmaceutical Technology and Development (PT&D) department. This role will support the entire PT&D portfolio. PT&D is the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Make a positive impact, in a team where it means more. In Operations, we have a big ambition to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.

Requirements

• BSc/PhD level education in a relevant Engineering field or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry.
• Minimum 7 years experience.
• Knowledge and application of cGMP requirements, Device and Combination Product requirements in major pharmaceutical markets (USA, Europe).
• Strong technical and scientific skills with proven experience in the development of packaging solutions for parenteral and/or Inhalation products.
• Strong experience with medical device or combination product commercialization, operations support, and significant packaging materials/components knowledge.
• Lean Six Sigma Green Belt or higher certification with strong problem-solving skills.
• Demonstrated ability to simultaneously handle multiple projects of variable complexity.
• Strong operational relationships with customers.
• Experience of leading cross-disciplinary delivery teams.

Responsibilities

• Bring a strong packaging perspective to the department, delivering our packaging strategy in a diverse, multi-skilled area.
• Support packaging activities on development projects from Phase 1 to the transfer to Commercial Manufacture.
• Lead the design & development, and testing of all packaging presentations for medical devices and combination products.
• Accountable for developing innovative, creative, and cost-competitive packaging solutions that meet the needs and requirements of our patients, sustainability objectives, and quality standards.
• Generate and review regulatory submission documents, plans, protocols, and reports ensuring that project objectives are met.
• Contribute and support relevant information to the Design transfer team for successful packaging transfer to AZ manufacturing operations and/or contract manufacturing sites.
• Ensure that work is performed in accordance with appropriate safety (SHE), quality, and compliance standards.
• Influence understanding and interpretation of packaging regulations.
• Represent specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data.
• Understand and influence developments within the industry.
• Contribute to the training and development of packaging colleagues by acting as coach/mentor.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees