Device Assembly Process Engineer

AstraZeneca • Gaithersburg, MD

6d • $79,337 - $119,005 • Onsite

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: Device/Combination Product Assembly Technical Leadership, Assembly Process Characterization, and Medical Device/Combination Product Design Transfer.

Requirements

• 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.
• 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.
• Suitable experience may include development of combination products and/or associated manufacturing processes, Quality oversight or validation of device/combination product assembly processes.
• 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.
• GMP process development experience, e.g. in technical services or validation.
• Device development or small molecule parenteral background.

Responsibilities

• 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.
• 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.
• 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)
• 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