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AstraZeneca · 5 hours ago

Associate Principal Packaging Engineer

US - Durham - NC

Full-time

Hybrid

Senior Level, Lead/Staff

7+ years exp

AstraZeneca is a leading pharmaceutical company, and they are seeking an Associate Principal Packaging Engineer to support 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 and quality standards while contributing to the training of packaging colleagues.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

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

Packaging EngineeringCGMP requirementsDeviceCombination ProductsLean Six Sigma Green BeltMedical device commercializationOperational relationshipsProblem-solving skillsCross-disciplinary team leadership

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

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca 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

2021 (2)

2020 (11)