Some opportunities happen only once in a lifetime
– like a job where you have the chanceto change lives.
At Alexion, people living with rare and devastating diseases are our Guiding Star.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.
We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do: This position will serve the role of Engineer III for device development of Alexion products including continuous product improvement within the Development function of Alexion.
The candidate will support device development activities for combination products.
You will be responsible for: Support Device Development project with Device control documentation.
Initiate and manage records in global development/ quality system for deviation, CAPA, laboratory investigation and change control including impact assessment.
Interface with DD SME, cross functional team, device suppliers as well as site quality for performance matrix.
Support remediation of design history file for combination products.
Support internal/ external audit Support supplier qualification for medical CRO/ CMO, consultants and development partners.
Communicate effectively, both verbally and in writing, internally across departments and with external stakeholders.
Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.
You will need to have: Experience in design control activities working in cGMP setting.
Experience with documentation and quality systems.
Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e.
FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements).
The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have: Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 4-6 year experience in medical device development.
Experience with injector based combination product preferred.
LI-JR1 Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.
Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.
Furtherinformation about Alexion can be found at: www.alexion.com .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.
The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants.
All US-based employees must comply with Alexion’s COVID-19 vaccination mandate.
Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees.
To begin aninteractive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodationsAlexion.com .
Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families.
Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease.
If you’re interested in career opportunities with AstraZeneca, click here .