Device Assembly Process Engineer

AstraZeneca•Gaithersburg, MD

About The Position

The candidate will support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices. Primary responsibilities will include: 1) Device/Combination Product Assembly Technical Leadership: Give to the operation of a fill-finish/assembly pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly. Develop risk assessment tools, study protocols and report templates. Provide technical rigor in experimental design and data analysis across projects. Carry out ongoing academic, regulatory and vendor literature review, maintain groundbreaking technical knowledge, and communicate findings to team 2) Assembly Process Characterization: Perform risk analyses and conduct laboratory or engineering studies to characterize processes. Test, analyze and interpret a range of assembly methods on device or combination product performance (e.g. injection time, glide force). Design process steps, establish associated operational design space and control strategy. Support engineering and Clinical/Commercial GMP runs at assembly sites. Review and approve batch records, validation protocols, and other GMP documents. Provide on-site support for assembly activities and support to close non-conformances. Support Regulatory writing for clinical and commercial filings. 3) Medical Device/Combination Product Design Transfer: Assist or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities for parenteral biopharmaceutical or synthetic drug products (including technical support for clinical technology transfer as required). Organize an internal sending unit team including development functions (formulation, process, device, analytical, packaging), operations, supply chain, project management and QA. Manage timelines and activities internally, communicate goals and track work you're doing at the receiving site. Manage DT documentation optimally. Some travel is required (typically 1 – 2 trips per year) in the US and abroad. Education & Experience: Educational requirements include a degree in Mechanical Engineering, Biomedical or related engineering or pharmaceutical science field. Bachelors degree and 5+ years OR Master's degree and 2+ years of med device or combination product experience. The candidate should have capability, skill and/or knowledge in most of the following areas: Biopharmaceutical / combination drug product development Combination product and cGMP regulations Assembly, label and packaging processes and equipment Validation of Equipment, Process and Shipping Configurations QbD, experimental design, statistics, data analysis Leadership and interpersonal communication Technical writing and documentation Experience: Suitable experience may include development of combination products and/or associated manufacturing processes, Quality oversight or validation of device/combination product assembly processes. Design Transfer experience or experience organizing and leading multi-functional teams is valuable. Knowledge of injection molding and materials science of polymers is helpful. A high degree of self-motivation, mechanical skill and technical rigor is required. Strong communication and technical writing skills are important. Though this position is in Development, we will consider strong candidates with GMP process development experience, e.g. in technical services or validation. We will also consider strong candidates from a device development or small molecule parenteral background. 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 groundbreaking new ways of working and encouraging unexpected teamworks. What’s Next? Are you ready to bring new insights and fresh thinking to the table? We have one seat available, and we hope it's yours.

Requirements

Educational requirements include a degree in Mechanical Engineering, Biomedical or related engineering or pharmaceutical science field.
Bachelors degree and 5+ years OR Master's degree and 2+ years of med device or combination product experience.
The candidate should have capability, skill and/or knowledge in most of the following areas: Biopharmaceutical / combination drug product development
Combination product and cGMP regulations
Assembly, label and packaging processes and equipment
Validation of Equipment, Process and Shipping Configurations
QbD, experimental design, statistics, data analysis
Leadership and interpersonal communication
Technical writing and documentation
A high degree of self-motivation, mechanical skill and technical rigor is required.
Strong communication and technical writing skills are important.

Nice To Haves

Design Transfer experience or experience organizing and leading multi-functional teams is valuable.
Knowledge of injection molding and materials science of polymers is helpful.
Though this position is in Development, we will consider strong candidates with GMP process development experience, e.g. in technical services or validation.
We will also consider strong candidates from a device development or small molecule parenteral background.

Responsibilities

Device/Combination Product Assembly Technical Leadership: Give to the operation of a fill-finish/assembly pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly. Develop risk assessment tools, study protocols and report templates. Provide technical rigor in experimental design and data analysis across projects. Carry out ongoing academic, regulatory and vendor literature review, maintain groundbreaking technical knowledge, and communicate findings to team
Assembly Process Characterization: Perform risk analyses and conduct laboratory or engineering studies to characterize processes. Test, analyze and interpret a range of assembly methods on device or combination product performance (e.g. injection time, glide force). Design process steps, establish associated operational design space and control strategy. Support engineering and Clinical/Commercial GMP runs at assembly sites. Review and approve batch records, validation protocols, and other GMP documents. Provide on-site support for assembly activities and support to close non-conformances. Support Regulatory writing for clinical and commercial filings.
Medical Device/Combination Product Design Transfer: Assist or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities for parenteral biopharmaceutical or synthetic drug products (including technical support for clinical technology transfer as required). Organize an internal sending unit team including development functions (formulation, process, device, analytical, packaging), operations, supply chain, project management and QA. Manage timelines and activities internally, communicate goals and track work you're doing at the receiving site. Manage DT documentation optimally. Some travel is required (typically 1 – 2 trips per year) in the US and abroad.

Benefits

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.

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