Senior Engineer - Engineering Drug Product Supply
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Mar 26, 2021
View more
- Discipline
- Marketing, Product Development/Management, Science/R&D, Pharmacology
- Required Education
- Other
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Senior Engineer - Engineering Drug Product Supply
Live
What you will do
Let's do this. Let's change the world. In this vital role you will be joining Facilities & Engineering (F&E) group within Development Supply Chain organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.
- Provide system ownership for Biopharmaceutical process equipment. 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.
- Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
- Ensure vital commissioning and qualification of systems is completed and interact with inspectors as necessary.
- Supervise systems to identify performance risks and implement risk reduction strategies.
- 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, and supporting engineering runs.
- Ensure systems are installed, operating safety and align with pertinent environmental health/safety practice, rules and regulations.
- Up to 10% domestic/international travel
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The team-oriented professional we seek is an engineer with these qualifications.
Basic Qualifications:
Doctorate degree
OR
Master's degree and 3 years of Engineering experience
OR
Bachelor's degree and 5 years of Engineering experience
OR
Associate's degree and 10 years of Engineering experience
OR
High school diploma / GED and 12 years of Engineering experience
Preferred Qualifications:
- Bachelor's degree in Chemical or Mechanical Engineering
- 6 plus years of relevant work experience with demonstrated ability in Biopharmaceutical operations/manufacturing environment
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment /systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and completion of capital projects
- Understand the processes of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, results-oriented, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
- Phenomenal teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
Thrive
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Equal Opportunity Statement
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 a 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 an accommodation.
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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