Amgen Engineer - Technical Investigator in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
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. 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, SEM material analysis, and Instron testing machines. They will be responsible for training new personnel, 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.
Perform device assessments of complaints and document results in a report using the electronic lab notebook.
Lead root cause analysis investigations for mechanical and/or electromechanical products.
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.
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 employee with these qualifications.
Master’s degree; OR
Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR
Associate degree and 6 years of related medical/biopharma development or Operations experience.
High school diploma / GED and 8 years of related medical/biopharma development or Operations experience
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 development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and thorough
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.