|Date Posted||April 27, 2022|
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Principal Engineer - Process Lead
What you will do
Lets do this. Lets change the world. Does the thought of building an entirely new site, from the ground up excite you? Do you love building and developing robust teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient, every time then check out this exciting new opportunity.
The Engineering Technical Authority (ETA) within Amgen Corporate Engineering leads the design effort for critical projects as well as provides technical expertise and direction across Amgens global operations network. This position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, Maintenance and Metrology functions. The Process Technical Lead will collaborate with the Director of the Process Systems team with a dotted line to the project technical lead, who is also a member of the ETA.
The Process Technical Lead provides coordination and oversite to a team of internal Amgen engineers to deliver the process equipment. They deliver the design specs and detailed equipment designs as part of Amgen integrated project delivery approach. They supervise process leads from the A&E firm, and the suppliers of the process equipment. They lead the development of all equipment design packages and review designs provided by the suppliers. The initial project scope includes the design and construction of a new greenfield drug substance site. The scope includes a manufacturing facility and equipment, warehouse, central utilities as well as administration, laboratory and site infrastructure. As part of this project, Amgen will have a strong focus on delivering a digitally enabled and sustainable facility aligned with our digital manufacturing strategy and our aggressive corporate sustainability goals. The successful Process Technical Lead will have extensive experience in Drug Substance Manufacturing and Equipment design, development, and implementation. Experience in the design and delivery of large capital projects is required.
The Principal Engineer/Sr Manager deploys engineering expertise from within the company (global and site-based specialists) as well as expertise from our industry to optimize Amgens assets throughout their life cycle
- Planning: Translate business needs into engineering technology and design solutions. Lead analysis of alternatives and recommendations for technical solutions in major projects. Lead Engineering in development and implementation of corporate initiatives, goals & projects.
- Design: Lead design and equipment selection of process equipment, utilities, laboratory and building systems to optimize quality and cost across the total life cycle of assets. Ensure appropriate use of technology, and alignment to standards/practices. Approve appropriate exceptions to Amgen standards and specifications.
- Construction: Provide engineering support during construction, resolve technical issues, and ensure project objectives are met. Ensure commissioning standards are developed and implemented during system qualification.
- Operations and Maintenance: Assist sites in troubleshooting, and remediation to prevent future occurrence throughout the network. Support the implementation of sustainable and digital solutions to advance performance.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will have these qualifications.
- Doctorate degree and 2 years of direct experience in Engineering or a related technical field OR
- Masters degree and 6 years of direct experience in Engineering or a related technical field OR
- Bachelors degree and 8 years of direct experience in Engineering or a related technical field AND
- Associate's degree and 10 years of direct experience in Engineering or a related technical field OR
- High School Diploma/GED and 12 years of direct experience in Engineering or a related technical field
- Extensive experience with Drug Substance manufacturing equipment design and delivery.
- Extensive experience in the delivery of capital projects as part of the design team
- Ability to provide direction and guidance to equipment vendors to deliver for the capital projects
- Experience in providing technical support to manufacturing facilities
- Track record of compliance in a highly regulated environment
- Ability to optimally lead and partner in matrixed organizations
- Successful deployment of continuous improvement methodologies (e.g., Lean, Six Sigma, Total Quality Management, Reliability Centered Maintenance, Root Cause Analysis tools, etc.)
- Demonstrated experience in selection of and implementation of design elements for improved sustainability.
- Leadership and planning capabilities to delivery critical projects and capabilities
- Capabilities to hire, develop and lead a diverse workforce
- Financial competence 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, fire codes, electrical codes, OSHA, LEED, Energy codes, Mechanical codes, Boiler and Pressure Vessel codes) 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.
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.
- Vast opportunities to learn and move up and across our global organization
- 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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.