Engineer

at  Amgen

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.

JOB DESCRIPTION

This Engineer position is in the Thermal Engineering group under Combination Product Operations. This position requires the application of diverse and advanced engineering & scientific principles in support of transportation testing and operation within Amgen.
The successful candidate will be responsible for managing transportation lab operation and performing lab related testing. The individual will actively participate in multi-functional teams to qualify shipping solutions that meet Amgen’s expanding business need and serve as the Subject Matter Expert (SME) for addressing and resolving technical issues or challenges related to cold chain shippers. In addition, the individual will lead the management of CAPA/Deviation/Change-control activities; perform technical assessment and studies; write technical reports, manuals, specifications, SOPs, and bill-of-materials with minimal supervision. This position also carries responsibilities for managing collaborative relationships with internal customers and external partners.

BASIC QUALIFICATIONS:

• Master’s degree; OR
• Bachelor’s degree and 2 years of Engineering experience; OR
• Associate’s degree and 6 years of Engineering experience; OR
• High school diploma/GED and 8 years of Engineering experience

PREFERRED QUALIFICATIONS:

• Engineering or Science degree: biotechnology, biomedical, chemical or mechanical preferred.
• Work experience in the pharmaceutical or biotechnology industry. Demonstrated accomplishment in manufacturing or supply-chain areas with strong fundamental knowledge on thermal packaging systems, packaging engineering, and/or material science, and/or transportation-quality systems.
• Demonstrated organizational, project management, technical problem-solving and (written & verbal) communication skills.
• Demonstrated ability to communicate and work with a range of technically and culturally diverse people, to influence them to execute for a common goal, and to deliver valuable results that meet high quality requirements within a tight schedule.
• Demonstrated skills in technical presentation, issue organization, and analytical problem solving.
• Demonstrated ability to successfully manage a multitude of tasks concurrently.
• Experience in project-management and CAPA/Deviation/Change control process.
• Familiar with the following programs/software: SAP, Trackwise, Minitab, Maximo, PLM, MS Office (Visio, Excel, Word, PPT), CDOCS, Efinity (Arriba), Smartsheet, etc.

RESPONSIBILITIES

• Complete all lab related testing per test protocols in accordance with operating standards, SOPs and regulatory requirements, while understanding safety precautions.
• Familiarity with lab testing equipment, e.g., Compression Tester, Vibration Systems, Environmental Chambers, Vacuum Systems, and Drop Tester.
• Responsible for planning and scheduling all lab related activities, such equipment calibration, maintenance, lab tour, etc.
• Manage lab budget/expense and supply inventory levels to satisfy testing demand.
• Able to solve and perform general maintenance on equipment to keep a test running.
• Collaborate with cross-functional teams (i.e. Research and Development, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory) on protocol review, testing preparation, change control process, deviation & CAPA, and controlled documentation.
• Assist other Engineers with internal experiments and studies; provide guidance on test method to be used.
• Apply engineering and project-management principles to qualify thermal shipping systems and temperature-recording/indicating devices in accordance with GMP procedures.