Senior Engineer - Packaging Design

AstraZeneca • Gaithersburg, MD

8d

About The Position

Are you ready to make a significant impact on patients' lives? As a Senior Engineer of Packaging Design, you will play a crucial role in the planning, design, development, qualification, and transfer of packaging materials. Your expertise will ensure the safe manufacture, storage, and transport of drug products throughout their lifecycle. Accountabilities: In this role, you will help AstraZeneca biologics operations achieve optimized packaging solutions that prioritize product protection, security, and sustainability. You will be responsible for planning, designing, developing, qualifying, transferring, and supporting the manufacturing of packaged products in compliance with business needs and regulations throughout a product’s lifecycle. AstraZeneca offers an environment where your work is valued and impactful. With a forward-looking mindset, you will be at the forefront of innovation, trialling the latest models and technologies to enhance reliability and excellence in our processes. Here, you'll be empowered to make decisions that prioritize patient needs while collaborating with product and process experts to drive excellence across the Quality network. Our inclusive community fosters camaraderie and encourages sharing knowledge and expertise across functions and regions. Ready to take on this exciting challenge? Apply now to join our team!

Requirements

• Bachelor’s degree in engineering or related field.
• Minimum of 3 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 and reports, specifications, SOPs, batch records, etc.

Nice To Haves

• Experience in device combination products packaging and assembly.

Responsibilities

• planning
• designing
• developing
• qualifying
• transferring
• supporting the manufacturing of packaged products in compliance with business needs and regulations throughout a product’s lifecycle

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees