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.
Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.
Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance bio-manufacturing facility in Holly Springs, North Carolina, a bio-manufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability; aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.
The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2025 for site completion.
Senior Engineer: Utilities System OwnerLive
What you will do
Lets do this. Lets change the world. The Senior Engineer System Owner will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.
The Utilities System Owner works with the Director of the Amgen North Carolina Facilities & Engineering group.Responsibilities include:
- Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
- Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
- Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of an argument if required to support the completion of the project.
- Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance as required to ensure systems are in proper working order.
- Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
- Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as required.
- Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing problem solving 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.
- Advance the use of condition based and predictive maintenance practices by incorporating data analytics where applicable.
- Own investigations of abnormal conditions through Deviation and business processes.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a dynamic, flexible and motivated individual with these qualifications.
Masters degree and 3 years of Engineering/Maintenance experience
Bachelors degree and 5 years of Engineering/Maintenance experience
Associates degree and 10 years of Engineering/Maintenance experience
High school diploma / GED and 12 years of Engineering/Maintenance experience
- Bachelors degree in Chemical, Mechanical, or Electrical Engineering
- 4+ years of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, and Clean Air generation and distribution; and as well as other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- 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
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and of capital projects
- Understanding of the process 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, ambitious, 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 work environment that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
- Ability for travel (domestic/international) in support of equipment design and fabrication
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 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 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.careers.amgen.com
Join UsIf 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.