Engineer/Senior Engineer - Manufacturing Sciences

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

Summary of the group:

Manufacturing Sciences develops biopharmaceutical medicines and produces GMP products for use in clinical trials. Engineering Science & Technology is a group within Manufacturing Services that provides engineering and technical support to clinical manufacturing and development.

This position is managed by the Associate Director of the Engineering Science & Technology group of Manufacturing Sciences within Bio-Process Development. The position is responsible for ensuring the reliability of process systems and equipment for multiple manufacturing and/or development areas at AstraZeneca’s Gaithersburg facilities, providing technical support and guidance to colleagues in area of expertise, applying developed solutions and supporting performance improvement projects while adhering to local best practice, safety and compliance standards. The Engineer will be supporting the development of new bioprocess technologies and cell therapy processes in addition to the manufacturing of monoclonal antibodies, viral products, antibody drug conjugates.

Main Duties & Responsibilities:

• Subject Matter Expert (SME) and technical owner of multiple Biotech manufacturing equipment and systems

• Provides technical support to team members and other AstraZeneca engineers by using existing knowledge and experience and by seeking out information to resolve daily operational problems.

• Participates in troubleshooting, maintenance, and process performance optimization

• Installs or replaces components and equipment. 

• Supports shutdown and return to service activities

• Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans

• Coordinates maintenance activities with Facilities, service contracts, and work of outside vendors.

• Participates in activities across Engineering function, helping ensure that agreed priorities are carried out and projects are delivered according to plan

• Provides input to continuous improvement activities, conducts root cause analysis and supports new product introduction

• Obtains quotes and purchases spare parts and equipment, and adds parts to the SAP inventory system

• Monitors equipment performance. Identifies equipment issues and develops technical solutions.

• Determines process requirements. Supports design, installation, and commissioning of new processes and equipment.

• Writes and reviews documentation including: user requirements, specifications, protocols, HECPs, JHAs, drawings, work instructions and reports

• Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs as needed. 

• Represents Manufacturing and Engineering Science & Technology on equipment projects managed by other engineering groups.

• Evaluates new equipment technologies. Participates in tech transfers.

• Provides on-call support as needed.

• Leads the planning, managing, and monitoring of major projects from concepts through implementation, or provides expert technical support to project manager carrying out these functions

• Provides technical advice and information to other function members. Mentors more junior staff

• Ensures compliance of own work and work of others with Safety, Health and Environment standards

• Keeps own knowledge of best practices and new developments up to date.

Educational and Experience Requirements

Engineer

• BS/BA degree preferred. Associates degree or High School Diploma acceptable with the following experience

3 yrs. experience with Bachelors