Career Category
SafetyJob Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Group Purpose:
Post Market Surveillance & Trending group is responsible for conducting science-driven evaluations to assess the safety and quality of Amgen’s combination products, medical devices, companion diagnostics, and digital health products. The group is responsible for post market surveillance, product complaints trending and data analytics. Additionally, the group analyses the potential impact of quality issues on patient/user safety across these products.
Job Summary:
The ISM Engineer is responsible for performing product complaints statistical excursion trending deep dives. Prepares product complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries, as well as generate process metrics to support process surveillance activities.
Key Activities:
Performs product complaints statistical excursion trending deep dives
Understand customer / patient use of Amgen’s packaged and/or distributed mechanical and/or electromechanical products
Understand manufacturing processes for Amgen’s packaged and/or distributed products.
Maintain close interaction with multiple functions including Quality (e.g. complaints, device quality, product quality, external supplier quality, manufacturing quality, quality engineering) and contribute to product / device design improvements
Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety’s perspectives
Prepares and interprets adverse events and product complaints data supporting integrated product surveillance activities
Prepares product and process surveillance metrics for internal safety and quality governance forums
Pulls complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries
Perform data verification of complaints data pulled for inspection requests
Applies analytical skills to evaluate complex situations using multiple sources of information
Contribute to technology innovation initiatives related to post market surveillance, including AI/ML and automation opportunities
Contribute to improvements in trending methodologies and process improvement opportunities
Support audits and inspections as appropriate
Knowledge and Skills
Required Knowledge and Skills:
Quality and/or manufacturing experience in biotech or pharmaceutical industry
Complaints or complaints trending within a development, manufacturing, or post-market environment
Knowledge of product complaints and adverse events intake and processing process
Ability to pull and create product complaints and/or adverse events data per request
Knowledge of medical devices or combination products, ideally Class II and Class III
Data querying skills and experience with data visualizations tools such as Tableau, Power BI, or Python
Preferred Knowledge and Skills:
Proven experience with mechanical and/or electromechanical medical devices
Knowledge of combination products and medical devices, including device safety monitoring regulations and standards
Ability to perform data analysis and derive insights
Education & Experience (Preferred)
Degree in Engineering or Life Science
5-9 years of quality and/or manufacturing experience as an engineer in the biotech or pharmaceutical industry
2+years of experience in complaints or complaints trending within a development, manufacturing or post-market environment, working with medical devices or combination products, ideally Class II and Class III
Experience with statistical trending methodology, preferably complaints
Strong data analysis experience and a passion for finding correlations across different datasets
Experience with data querying and business intelligence tools
Strong presentation and teamwork skills
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided with 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 accommodation.
.