Associate Principal Packaging Engineer

US AstraZeneca offices will be closed from December 25th to January 1st re-opening January 2nd. We encourage you to apply to jobs of interest and we will review applications upon our return

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.

What you will do:

We will rely on you to bring a strong packaging perspective to the department delivering our packaging strategy in a diverse multi-skilled area and supporting our packaging activities on development projects from Phase 1 to the transfer to Commercial Manufacture. You will work with Development and Operations colleagues across the company.

• Lead the design & development and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion.

• Accountable for developing innovative creative and cost-competitive packaging solutions that meet the needs and requirements of our patients our sustainability objectives and our quality standards.

• Generate and review regulatory submission documents plans protocols and reports ensuring that the project objectives are met (Design History File documentation).

• Contribute and support relevant information to the Design transfer team to enable 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 (technical resource & budgetary).

• Understand and Influence developments within the industry.

• Contribute to the training and development of packaging colleagues by acting as coach/mentor as appropriate.

Minimum Qualifications:

• BSc/PhD level education in a relevant Engineering field (Packaging Engineering Mechanical Engineering Biomedical Engineering Materials Engineering Chemical Engineering) 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

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations journey towards the 2025 strategy. Build on our foundations of high performance through agility responsiveness reliability and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by a supportive team be part of accelerating our operational excellence with innovations in cutting-edge science Lean ways of working and fast-changing digital technologies.

Call to Action:

Ready to make a difference Apply today!

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