development engineer Durham, NC
Job description
Would you like to apply your expertise in the development of packaging solutions in a company that follows the science and brings life changing medicines to patients. If so, our Packaging Engineer position in Durham, NC; Gothenburg, Sweden; or in Macclesfield, UK would be a great fit!
In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
If you have the passion and the drive to accelerate growth and make people’s lives better – then this is the place for you.
We have an open position for a Packaging Development Associate Principal Engineer (Medical Device Combination Products) based in our Pharmaceutical Technology and Development (PT&D) department. This role will support across the entire PT&D portfolio. PT&D are 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.
What you’ll 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, supporting our packaging activities on development projects from Phase 1 to the transfer to Commercial Manufacture. You will work with Development and Operations packaging colleagues across the company. Responsibilities include;
Lead the development, testing, and validation of all packaging presentations for medical device and combination products to achieve project targets in a timely fashion.
Accountable for developing innovative, creative and cost competitive packaging solutions which 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 laboratories
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:
Bachelor's degree with a minimum of 5 years experience
Degree in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the medical device and / or biopharmaceutical industry.
Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USFDA, EMA..)
Demonstrated ability to simultaneously manage multiple projects of variable complexity.
Strong experience with medical device or combination product commercialization, operations support, and materials/ components.
Preferred Qualifications:
Lean Six Sigma Green Belt or higher certification with strong problem solving skills
Experience of leading cross disciplinary delivery teams
Why AstraZeneca:
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
What’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
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