|Location||Newbury Park, California|
|Date Posted||June 22, 2022|
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
What you will do
Lets do this. Lets change the world.
The Senior Engineer is responsible for planning, design, construction, and operations and maintenance technical support of Amgen manufacturing infrastructure, world-wide. The Engineering Technical Authority (TA) is responsible for technical direction, leadership, guidance and support for a specific array of process systems within an area of responsibility, such as Upstream Processes, Downstream Processes, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical subject matter experts, the TA will demonstrate engineering expertise both in the company and industry to optimize the life cycle management of Amgens assets, and is accountable for performance and reliability across multiple sites. This position is in the Process System Engineering team with initial emphasis on drug substance capital project support, subsequent responsibilities may include technical network management and other project engineering leadership.
The successful candidates role will include responsibilities as a process equipment design lead as part of our Flexbatch DS facility process design team for Amgen-North Carolina (ANC). The individual will lead the design of equipment for various unit operations as part of the process and facility design team. They will be responsible for equipment design including providing direction to the A&E partner design SMEs, and oversight of the equipment manufacturer during the fabrication phase. They will develop plans and lead the execution of factory acceptance testing, installation and integration design and execution.
Planning: Working with clients, as appropriate (e.g. PD, Quality, Manufacturing), develop and specify engineering standards, specifications, equipment selection and design. Develop metrics to support procurement strategies for equipment, inventory management, spares and preventative maintenance. Manage and track changes to specifications and standards, and system configuration.
Design: Ensure consistency to standards and good engineering practices. Lead design of new systems in support of projects and new technology deployment. Ensure designs optimize the total life cycle of the asset, from both a cost and effectiveness standpoint.
Construction: Use their TA network to provide engineering support during the construction process, including responses to RFIs, resolving complex technical issues and conflicts, supporting overall project objectives.
Commissioning: Ensure commissioning and qualification standards are developed and used. Use their network to provide engineering support to commissioning and qualification.
Operations: Support development of, or approve operation procedures for the safe, efficient and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support NC/CAPA investigations related to equipment failures.
Maintenance: Support systems failure analysis, approve maintenance standards and techniques. Support and review reliability and failure data, and implement actions to improve effectiveness, and reliability of systems. Assist the sites in system troubleshooting, and take action as necessary to prevent future occurrence throughout network.
Management: Lead their technical network. Makes use of expertise at the site and corporate levels for solving problems and deploying solutions across all sites. Identify and resolve issues and conflicts. Provide mentoring of other members in their network. Ensure technical decisions for assigned systems are optimized with those managed by other TAs. Remain current on state-of-the-art for systems for adoption of new techniques and technology within Amgen. Represent Amgen with outside firms, technical societies and regulatory bodies.
This role involves travel up to 30% including overnight stays
Flexibility for remote work may be considered within additional locations near an Amgen site.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineer professional we seek is an employee with these qualifications.
Masters degree and 3 years of Engineering experience
Bachelors degree and 5 years of Engineering experience
Associates degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience
Demonstrated ability to lead the design of process equipment for new facilities and to balance competing factors to deliver equipment that meets process, quality and operability requirements.
Financial foresight to deploy initiatives that add shareholder value
Excellent communications skills, strong facilitation talent, and executive presence to drive multi-functional objectives across Amgens international network
Strong analytical skills to identify potential improvement opportunities
Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation
Knowledge of applicable laws (e.g. cGMP, building codes, Boiler and Pressure Vessel codes, etc.), to ensure compliance. Represent Amgen with outside firms, technical societies and regulatory bodies.
Ability to develop, implement and apply tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results.
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and improve 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. 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.
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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.