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.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly designed, activity- based work spaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the group:
This position will be managed by an Associate Director Engineer within the Engineering Science and Teachnology 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, provides 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 manufacturing of monoclonal antibodies, viral campaigns, antibody drug conjugation, and the cell therapy technology.
Main Duties & Responsibilities:
This position will be responsible for providing on the floor manufacturing support for an assigned manufacturing area.
Monitors equipment performance. Identifies equipment issues and develops technical solutions. Performs troubleshooting, maintenance, and process performance optimization. Supports shutdown and return to service activities.
Subject Matter Expert (SME) for Biotech manufacturing equipment and systems, providing 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.
Coordinates maintenance activities with Facilities / Coordinates service contracts and work of outside vendors. Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans.
Provides input to continuous improvement activities, conducts root cause analysis and supports new product introduction. Participates in activities across Engineering function, helping ensure that agreed priorities are carried out and projects are delivered according to plan.
Leads and participates in projects of varying sizes and complexity. Determines process requirements. Supports design, installation, and commissioning of new processes and equipment. Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs. Independently performs GMP change control activities.
Writes and reviews both cGMP and non-GMP documentation, including SOPs, validation protocols, user requirements, specifications, JHAs, drawings, work instructions and reports
Education & Experience Requirements:
Associate Engineer:
BS/BA Engineering degree preferred. 0-2 yrs. experience with Bachelors.
Associates degree and/or High School Diploma acceptable with sufficient experience
2-3 yrs. experience with Associates
3-5 yrs. experience with High School Diploma
Required Skills:
Good trouble shooting and problem-solving skills
Good oral and written communication skill
Desired Skills:
Ability to work with minimum supervision
Demonstrated technical skills in supporting GMP manufacturing
Good interpersonal skills
Hands on mechanical, electrical and/or electronic skills
Experience with operating and/or maintaining biotech manufacturing equipment
Project management experience and GMP change management experience
Demonstrated ability to work effectively within a large network / matrix organization
The annual base pay (or hourly rate of compensation) for this position ranges from $. 65,470.40 - 98,205.60 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.
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.