Device Assembly Process Engineer

Location: Gaithersburg, Maryland, United States of America

Employment Type: Full time

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.

The annual base pay (or hourly rate of compensation) for this position ranges from $ 79,336.80 - 119,005.20 USD Annual, 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. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.