What are the responsibilities and job description for the Engineer - Complaints Technical Investigator position at Amgen?
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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 lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Engineer - Complaints Technical Investigator
What you will do
Lets do this. Lets change the world. In this vital role you will conduct forensic and technical evaluations of product complaint units for Standard and Advanced complaint investigations associated with product design, manufacturing and / or usability issues. This role understands customer / patient use of Amgens packaged and / or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation
Responsibilities :
- Lab-based evaluation of returned product complaint units, including the use of equipment such as CT scanners and optical microscopes
- Generate technical investigation reports in accordance with applicable procedures using electronic documentation systems, such as the Holistic Lab Execution Environment (HLEE)
- Provide input to engineering for product improvements
- Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
- Support root cause investigations to identify the failure mode for Amgens products and associated components due to product complaint
- Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.
Primarily lab-based, the role is a combination of onsite 3 times per week (average) for complaint returns assessment and / or laboratory equipment setup, development and validation of test methods. Amgen provides a flexible work environment, allowing staff to work from home or from the office for those days not required to be in the lab.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an Engineer with these qualifications.
Basic Qualifications :
Masters degree
Bachelors degree and 2 years of Operations / investigative experience
Associates degree and 6 years of Operations / investigative experience
High school diploma / GED and 8 years of Operations / investigative experience
Preferred Qualifications :
What you can expect of 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, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :
Apply now
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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 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.
