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Company

Original Job Post

AstraZeneca · 1 week ago

Principal Engineer, Packaging Design

Philadelphia, PA

Full-time

Onsite

Senior Level

14+ years exp

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BiopharmaBiotechnology

Actively Hiring

Comp. & Benefits

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Responsibilities

Plan, design & develop, qualify, transfer, and support the manufacturing of packaged products in accordance with business needs and laws/regulations throughout a product’s lifecycle.

Lead the packaging group within biologics GTO to achieve best-in-class, optimized packaging.

Progress a packaging project from inception to commercialization, including packaging materials, designs and manufacturing processes, qualification, validation, and systems.

Design packages with auto-CAD for secondary packaging systems for vials and combination products (accessorized pre-filled syringes, auto-injectors) and tertiary systems.

Design shipping qualification studies (real and simulated with accelerometers).

Transfer and support assembly, label and pack production.

Author quality management system (QMS) documents: change controls, CAPAs (Corrective Actions / Preventive Actions) and deviations.

Author study protocols, reports, specifications, SOPs, batch records, etc.

Qualification

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Packaging DesignAutoCADShipping QualificationManufacturing ProcessesCGMPsRegulatory ComplianceQuality ManagementDocument AuthoringProblem-SolvingInterpersonalOrganizationalCollaborationCommunicationProduct SerializationTraceability

Required

Bachelor’s degree in engineering or related field.

Minimum of 14 years of significant engineering or operational experience.

Excellent problem-solving abilities.

Strong interpersonal, organizational, collaboration, and communication skills.

Demonstrated ability to progress a packaging project from inception to commercialization, including packaging materials, designs and manufacturing processes, qualification, validation, and systems.

Experience designing packages with auto-CAD for secondary packaging systems for vials and combination products (accessorized pre-filled syringes, auto-injectors) and tertiary systems.

Experience in designing shipping qualification studies (real and simulated with accelerometers).

Experience in transferring and supporting assembly, label and pack production.

Knowledge of current Good Manufacturing Practices (cGMPs), packaging laws, regulations, and guidance, and experience authoring quality management system (QMS) documents: change controls, CAPAs (Corrective Actions / Preventive Actions) and deviations.

Authoring study protocols, reports, specifications, SOPs, batch records, etc.

Ability to travel to AZ site locations as needed. up to 20%

Preferred

Experience in product serialization for tracking and traceability.

Company

AstraZeneca

Glassdoor

4.1

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

Founded in 1999

Cambridge, Cambridgeshire, GBR

10,001+ employees