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Engineer - Technical Investigator

Employer
Amgen
Location
Thousand Oaks, California
Start date
Nov 18, 2023

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Live

What you will do

Lets do this! Lets 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 Amgens 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.

Responsibilities:
  • 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.

Win

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.

Basic Qualifications:
  • Masters degree; OR

  • Bachelors 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

Preferred Qualifications:
  • Masters or Bachelors 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

Thrive

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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Telephone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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