Associate Principal Engineer - Packaging Design

Role Summary

Associate Principal Engineer - Packaging Design responsible for planning, designing, and developing packaging materials to ensure the safe manufacture, storage, and transport of drug products, optimizing packaging for protection, security, and sustainability.

Responsibilities

• Plan, design, develop, qualify, transfer, and support the manufacturing of packaged products in alignment with business needs and regulatory requirements.
• Progress packaging projects from inception to commercialization, including packaging materials, designs, manufacturing processes, qualification, validation, and systems.
• Design packaging using AutoCAD for secondary packaging systems (vials and combination products) and tertiary systems; consider accessorized pre-filled syringes and auto-injectors.
• Design shipping qualification studies (real and simulated with accelerometers) and support transfer and production of assembly, label, and pack operations.
• Maintain knowledge of cGMPs, packaging laws and guidance; author QMS documents (change controls, CAPAs, deviations) and create study protocols, reports, specifications, SOPs, and batch records.

Qualifications

• Required: Bachelor‚Äôs degree in engineering or related field.
• Required: Minimum of 5+ years of significant engineering or operational experience.
• Required: Excellent problem-solving abilities.
• Required: Strong interpersonal, organizational, collaboration, and communication skills.
• Required: Demonstrated ability to progress packaging projects from inception to commercialization including packaging materials, designs and manufacturing processes, qualification, validation and systems.
• Required: Experience designing packages with AutoCAD for secondary packaging systems for vials and combination products (accessorized pre-filled syringes, auto-injectors), and tertiary systems.
• Required: Experience in designing shipping qualification studies (real and simulated with accelerometers).
• Required: Experience in transferring and supporting assembly, label and pack production.
• Required: Knowledge of cGMPs, packaging laws, regulations, and guidance; experience authoring QMS documents (change controls, CAPAs, deviations).
• Required: Authoring study protocols and reports, specifications, SOPs, batch records, etc.

Desirable Skills

• Experience in device combination products packaging and assembly.

Education

• Bachelor‚Äôs degree in engineering or related field.