Device Assembly Process Engineer

Job Description:

Are you passionate about Device Assembly Process Engineering? Do you have the expertise to drive innovation in biopharmaceutical device assembly? We are seeking a skilled professional to enhance our capabilities at AstraZeneca. If you're eager to apply your skills to complex assembly processes and make a significant impact in our department, we want to hear from you!

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 engineeringprinciples, modeling, simulation tools, and statistical analysisto 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 1-3trips per year) in the US and abroad.

Education & Experience:
Senior engineer will be expected to have a relevant Engineering discipline holding a BS degree with 13-15 years of experience or an MS degree with 10-13 years of relevant experience. Engineer will be expected to have a relevant Engineering discipline holding a BS degree with 10-13 years’ experience or an MS degree with 8-10 years of relevant 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 beneficial.  A high degree of self-motivation, mechanical skill and technical rigor is required.Strong communication and technical writing skills are crucial. 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.