Alexion Pharmaceuticals, Inc. · 5 hours ago
Associate Principal Packaging Engineer
Durham, North Carolina, United States of America
Full-time
Hybrid
Senior Level, Lead/Staff
7+ years expAlexion Pharmaceuticals, Inc. is seeking a Packaging Development Associate Principal Engineer in their Pharmaceutical Technology and Development department. This role involves leading the design and development of packaging solutions for medical devices and combination products, ensuring compliance with safety, quality, and regulatory standards.
BiotechnologyHealth CareMedicalTherapeutics
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
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
Qualification
Required
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
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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