Lab Test Technician - Combination Product Operations Mechanical Platforms

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.

What you will do

Lets do this. Lets change the world. In this vital role you will support testing of Amgens autoinjector and Combination Product drug delivery systems. The Lab Test Technician possesses experience and expertise in coordinating and implementing complex testing, analysis, and documentation supporting the development of commercial medical devices. In support of Amgens mission to serve patients, the Combination Product Operations group works to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience. This position directly supports mechanical autoinjector platform engineers responsible for meeting fast paced development timelines. The Test Technician may also interact with global and multi-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include the planning, execution, solving, and recording/reporting of critical test activities to support Combination Product development.

• Hands on testing and conditioning of autoinjector devices following established and developmental procedures.
• Safe and accurate operation of complex test equipment, such as Instron tensile tester, digital balances, and automated test equipment.
• Coordinates with Test Program Leads (TPL), supervisors, and external test vendors to achieve daily, weekly, and monthly test output breakthroughs.
• Thoroughly and accurately documents test activities and results within digital lab notebooks, per Amgens internal procedures, and in line with common Good Documentation Practices.
• Solves problems and provides technical expertise to Sr. Engineers for observations encountered during testing.
• Identifies test abnormalities/anomalies/unexpected results and clearly communicate these observations to development engineering team.
• Supports design control and technical documents including test/verification plans, test protocols, test reports, engineering assessments, design outputs, and technical recommendations.
• Ensures tests methods and test protocols are continuously reviewed and updated in a sound and robust framework with high focus on eliminating test errors.
• Prepares communications to Sr. Engineers in support of recommendations and assessments.
• Develops, complete, and reviews mechanical specifications, development plans, characterization plans, and other related development documents for assigned projects.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self starter with these qualifications.

Bachelors degree

Associates degree and 4 years of directly related GMP experience

High school diploma / GED and 6 years of directly related GMP experience

• 1 or more years of experience as a test or metrology technician in a medical device field.
• Experience leading complex mechanical test/metrology efforts, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)
• Experience handling medical devices containing sharps and/or drug product.
• Familiar with Good Documentation Practices and their application.
• High attention to detail, specifically in following and implementing established and in development test procedures and documenting results in digital lab notebooks.
• Ability to identify test abnormalities/anomalies/unexpected results and clearly communicate these observations to development engineering team.
• Capable of working on different projects in a deadline driven environment.
• Experience in drug/device Combination Product design and development.
• Background in development, commercialization, and lifecycle management of medical devices.
• Experience with material & test specification generation, protocol/report authorship, process and test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position.
• Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601)

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.

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.

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

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.

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