If you have a desire to make a meaningful contribution to Combination Product Commercialization and On Market Technical (OMT) support for Parenteral Devices in a leading pharmaceutical company, then join us!

At AstraZeneca, we are in the business of making a substantial difference to patient health, of helping to ensure that those who can benefit from our medicines are provided access to them, building deep and lasting connections with our many stakeholders, and honoring the countless ways we are connected and united through health.

The Device Engineer will lead and/or make strong technical contributions within cross-functional Combination Product Commercialization and On Market Technical (OMT) support teams. Responsible for successful OMT support for Parenteral Combination Products including design, development, manufacturing, and commercialization deliverables, and ensuring that device design, component selection, manufacturability, and testing specifications and methods meet product needs. To be successful the candidate must effectively work with staff and leaders in Operations, Global External Sourcing, Global Supplier Quality, Device Development, Device Quality, Regulatory Affairs, and across other areas in AstraZeneca. Strong communication skills are required including succinct and effective presentation of technical materials during technical meetings. This role will support and/or lead technical activities related to manufacturing, feasibility, design changes, and commercialization with both internal and external partners, including Device suppliers. Problem Solving, Design Changes, and commercialization activities must be conducted in compliance with applicable processes/procedures, standards, and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. The West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors (includes Device Assembly, Packaging and Labelling) that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate community outreach, sustainability, and social events.

What you will do:

• Life-cycle management of Parenteral Device Combination Products, including technical strategy, device control strategy, issue support, change implementation, knowledge management, and DHF oversight.

• Lead or be a strong technical contributor to a cross-functional team to enable robust manufacture through the life-cycle for a wide portfolio of Parenteral Combination Products in addition to synthetic molecule device platforms as they transition into commercial supply.

• Author, maintain and compile Design History File content and Design Change Impact Assessments (i.e. Provide technical direction for the evaluation and implementation of changes)

• Design and/or provide technical studies/assessments (e.g. feasibility activities) that drive robust product/process/testing performance.

• Author and review technical specifications and design control documentation (Design and Development Plans, FMEAs, User Requirements Specifications, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, and Design Transfer)

• Drive a Quality approach and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. risk management, Design Controls, ISO standards, etc.)

Education:

• Bachelor's degree and/or Master's degree in Mechanical or Biomedical Engineering, or related subject area/technical field.

Required:

• Minimum of one year of experience in technical roles supporting Medical Devices and/or within Combination Products.

• Knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC), as well as other applicable standards required (ISO 11608 series, ISO 62304, etc.).

• Excellent leadership skills to support and/or lead a cross-functional team and ensure the success of the project.

• Experience in working with external development and commercialization partners and suppliers is desirable.

• Development and On Market Technical experience with combination products including injection (pre-filled syringes, pens, auto-injectors).

• A track record of working within a matrix organization effectively with a highly cross-functional and collaborative environment is required.

Next Steps – Apply today!

Are you ready to bring new insights and fresh thinking to the table? We have one seat available, and we hope it’s yours. Curious to know more, then please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well-qualified for this opportunity. Know someone who would be an outstanding fit, please share this posting with them.

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• About Operations: https://www.youtube.com/watch?v=gak5Ham8oUw

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Date Posted

Closing Date

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.