Device Assembly Process Engineer

Gaithersburg, MD

Employer:	AstraZeneca
Job Type:	Full Time
Description
Position Overview: As a Biopharmaceutical Device Assembly Process Engineer, you will provide technical support to high-risk, high-impact projects across multiple territories. You will act independently, demonstrating broad functional capabilities and leadership within your role. Primary Responsibilities: Leadership & Collaboration: Lead small cross-functional teams with minimal oversight, mentoring junior staff and contributing to high-impact programs. Engineering Principles: Independently apply engineering principles to craft and develop robust devices, methods, and processes that align with patient, molecule, and business needs. Risk Analysis & Testing: Perform risk analyses and conduct laboratory studies to characterize assembly processes, testing and interpreting various assembly methods for device performance (e.g., injection time, glide force). Process Establishment: Establish assembly process steps, operational design space, and control strategies while conducting design for manufacturability and assembly assessments. Laboratory Contribution: Support the operation of a fill-finish/assembly laboratory, which includes vial and syringe filling, lyophilization, and device assembly. Problem-Solving: Use engineering principles, modeling, simulation tools, and statistical analysis to solve complex problems efficiently. GMP Support: 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. Regulatory Compliance: Contribute to regulatory writing for clinical and commercial filings, ensuring compliance with industry regulations and standards, including design controls and risk management. Proactive Program Management: Anticipate potential design and process challenges, analyze issues, provide practical solutions, and handle consequences of failures. Interdepartmental Teamwork: Drive collaborations that enhance efficiency and effectiveness across departments and represent the function in senior review forums. Safety Standards: Ensure compliance with established Safety, Health, and Environment standards in all work. Travel Requirements: Some travel is required (typically 1-3 trips per year) in the US and abroad. Why AstraZeneca? At AstraZeneca, we accept change and seize opportunities to innovate. Delivering life-changing medicines requires boldness-recognizing potential and acting on it. Join us in redefining what a biopharmaceutical company can be. We are pioneering new ways of working and fostering unexpected collaborations. What's Next? Are you ready to bring new ideas and fresh thinking to the table? We have one seat available, and we hope it's yours. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=e n The annual base pay (or hourly rate of compensation) for this position ranges from $ 104,270.40 to $ 156,405.60 , either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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.

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Device Assembly Process Engineer

Gaithersburg, MD

Description