Associate Principle/Principle Medical Device Packaging Engineer Macclesfield, England
Job description
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 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.
The Role
We have an open position for an Packaging Development Associate Principal Engineer 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 Requirements –Education and Experience
- BSc/PhD level education in 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.
- Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USFDA, EMA..)
- 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 materials/components.
- Lean Six Sigma Green Belt or higher certification with strong problem solving skills
- Demonstrated ability to simultaneously manage multiple projects of variable complexity.
- Excellent communication skills and strong operational relationships with customers
- Experience of leading cross disciplinary delivery teams
Bring out the best in each other, and yourself, by working together as one!
Be appreciated for your contributions. Our culture of recognition and reward means each of us feels supported and empowered to step up and take responsibility. With all the tools you need to excel at every level, coupled with ongoing constructive feedback and coaching, there’s no better place to bring out your best.
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.
In PT&D we understand the importance of managing the demands of both home and work life. To support this, many of our staff work flexibly in different ways, including working part-time, regular home-working, flexible start/finish times etc. We will consider requests for flexible working for this role and encourage applicants to talk to us at interview about the flexibility you need.
What’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Competitive Salary and Benefits
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
