Career Category
Engineering
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Senior Engineer
What you will do
Let’s do this. Let’s change the world. In this vital role you will work with the Sr. Engineering Manager and will provide engineering support for the Drug Substance facilities.
Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
Ensure necessary commissioning and qualification of systems is completed and interact with inspectors
Develop metrics-based performance focused on the maintenance systems effectiveness and operating level performance.
Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, identifying spare parts, job plan development and supporting engineering runs.
Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations
Responsible for determining appropriate CAPAs, action plan development, QMTS data entry, owns the record, initiate child CAPA’s and CAPA EVs, timely closure and responses, provision of technical data and reports.
Use tools and techniques of continuous improvement wherever possible. Establish equipment monitoring parameters and control limits. Routinely provide updates on metrics. Provide 2nd tier trouble shooting to support ops and maintenance groups as follow on from tier 1 initial problem solving. Change over reduction projects. Failure trending
Up to 10% domestic travel
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 leader with these qualifications.
Basic Qualifications:
Doctorate degree
OR
Master’s degree and 2 years of engineering experience
OR
Bachelor’s degree and 4 years of engineering experience
OR
Associate’s degree and 8 years of engineering experience
OR
High school diploma / GED and 10 years of engineering experience
Preferred Qualifications:
Bachelor’s degree in Biotechnology, Industrial, Chemical or Mechanical Engineering
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes…