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Packaging and Labeling Engineer

Location Gaithersburg, Maryland, United States Job ID R-227493 Date posted 22/05/2025

As a Packaging and Labeling Engineer, you'll coordinate the design, selection, and implementation of cold chain shipping packages for cell therapy products and critical materials. Your work will align with clinical trial and commercial distribution needs, regulatory compliance, and production capabilities. You'll develop documentation for packaging components and pursue new packaging concepts to improve functionality and sustainability, contributing to our CO2 reduction goals.

Responsibilities:

- Lead packaging development projects using various pharmaceutical packaging materials.
- Implement projects encompassing secondary to tertiary packaging development, including labeling and combination product kits.
- Generate, review, and approve test plans and reports for packaging qualification and validation.
- Implement cost-saving and sustainability initiatives related to package design and materials to support the company's CO2 reduction goals.
- Lead the lifecycle of label design, development, and production to ensure compliance with global regulatory standards.
- Coordinate with cross-functional teams including CMC, regulatory, quality, and manufacturing to ensure labeling meets all legal and regulatory compliance.
- Review change controls, deviations, and CAPAs related to packaging components and performance.
- Coordinate packaging activities at third-party logistics providers or CMOs.
- Travel to vendor and manufacturing locations to support packaging projects (up to 20% travel).

Essential Skills/Experience:
- Five (5) years with BS/BA, or three (3) years with MS/MA, in package engineering, mechanical engineering or engineering science.
- Minimum of three (3) years of experience in biotech, pharmaceutical, or medical device packaging.
- Experience in secondary to tertiary packaging development for new product launches.
- Coordination and completion of qualification for new package designs and materials.
- Development of component specifications.
- Basic knowledge of different packaging materials: corrugate containers, phase change materials, cartons, labels, temperature controlled packaging, specimen collection kits, etc.
- Strong focus on sustainable practices and materials to reduce environmental impact.
- Proficiency in label and package design software tools, along with experience in handling label content version control.
- Familiarity and understanding of cGMP, GDP, and DG regulations in the pharmaceutical industry.
- Knowledge of healthcare logistics is essential; knowledge of advanced therapies is a plus.
- Excellent communication and interpersonal skills for effective collaboration with internal teams and external partners.

AstraZeneca offers an environment where you can feel a strong connection to the patient. It's what drives us every day as we unite behind one mission: finding the best solutions to put our patients first. You'll play a meaningful role in delivering our innovative medicines until they reach those who need them most. With constant new products and launches, there's never been a better time to join our Supply Chain team. We thrive on challenges, continuously seeking new ways to deliver life-changing medicines. Our diverse team is connected globally, interpreting science and applying manufacturing excellence. Here, you'll find a safe space that encourages participation, sharing ideas, and problem-solving. If you're driven, adaptable, and ready to make a big impact, this is the place for you.

Ready to take the next step? Apply now to join us in making a difference!

The annual base pay for this position ranges from

$85,012.00 - $127,518.00.Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

10000542 D SULO Operations

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.