Engineer - Technical Investigator

Career Category

Job 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer - Technical Investigator

What you will do

Let’s do this! Let’s change the world!

Amgen is currently seeking a complaint's investigation technical investigator in our Complaints Trending and Investigation group (CT&I). This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of Amgen’s mission to serve patients, the Complaints Trending and Investigation group at Amgen is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The complaints investigation technical investigator will lead and perform the device assessment of complaint samples using equipment such as the CT scanner, Microscope, and Instron testing machines. They will be responsible for tracking and monitoring the assessments to ensure completion on time, authoring and reviewing the assessment report, and communicating the findings and results to management and multi-functional team as required. They will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting root cause analysis.

They will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, leading the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. They will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Responsibilities:

• Perform device assessments of complaints and document results in a report using the electronic lab notebook.

• Train and support onboarding of new personnel in performing device assessments and use of the CT&I equipment.

• Complete evaluation and deliver assessment report on time per Amgen requirements.

• Support the implementation and management of the lab infrastructure, including all equipment used for investigations and lead monthly lab safety inspections

• Provide requirements for lab and investigational equipment to device development teams in support of new device platforms and development of test methods.

• Perform characterization testing and support data gathering for investigations.

• Lead root cause analysis investigations for mechanical and/or electromechanical products.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 8 years of medical/biopharma development or Operations experience OR

• Associate’s degree and 6 years of medical/biopharma development or Operations experience OR

• Bachelor’s degree and 2 years of medical/biopharma development or Operations experience OR

• Master’s degree

Preferred Qualifications:

• Master’s or Bachelor’s in Engineering, Science or Biomedical

• 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment

• Experience in lab environment

• Demonstrated competency in root cause analysis methodology

• Experience with assessment writing, process and test de