Device Assembly Process Engineer

AstraZeneca - Frederick, MD

Full-time - Mid Level

Frederick, MD

Chemical Manufacturing

About the position

The Device Assembly Process Engineer at AstraZeneca is responsible for providing technical support to high-risk, high-impact projects across multiple territories. This role requires independent action, broad functional capabilities, and leadership, focusing on the development and optimization of biopharmaceutical device assembly processes.

Responsibilities

• Lead small cross-functional teams with minimal oversight, mentoring junior staff and contributing to high-impact programs.
• Independently apply engineering principles to craft and develop robust devices, methods, and processes that align with patient, molecule, and business needs.
• Perform risk analyses and conduct laboratory studies to characterize assembly processes, testing and interpreting various assembly methods for device performance.
• Establish assembly process steps, operational design space, and control strategies while conducting design for manufacturability and assembly assessments.
• Support the operation of a fill-finish/assembly laboratory, which includes vial and syringe filling, lyophilization, and device assembly.
• Use engineering principles, modeling, simulation tools, and statistical analysis to solve complex problems efficiently.
• Assist in engineering and clinical/commercial GMP runs at assembly sites, reviewing and approving batch records and validation protocols, while providing on-site support and resolving non-conformances.
• Contribute to regulatory writing for clinical and commercial filings, ensuring compliance with industry regulations and standards, including design controls and risk management.
• Anticipate potential design and process challenges, analyze issues, provide practical solutions, and handle consequences of failures.
• Drive collaborations that enhance efficiency and effectiveness across departments and represent the function in senior review forums.
• Ensure compliance with established Safety, Health, and Environment standards in all work.

Requirements

• Bachelor's degree in engineering or a related field.
• Experience in biopharmaceutical device assembly processes and engineering principles.
• Strong problem-solving skills using engineering principles, modeling, and statistical analysis.
• Knowledge of GMP regulations and experience in clinical/commercial runs.
• Ability to lead cross-functional teams and mentor junior staff.

Nice-to-haves

• Experience with regulatory writing for clinical and commercial filings.
• Familiarity with risk management and design controls in biopharmaceuticals.
• Experience in laboratory operations related to fill-finish and assembly processes.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Eligibility for equity-based long-term incentive program