Principal Automation Engineer
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 Automation EngineerLive
What you will do
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 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.
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 2024 for site completion.
Lets do this. Lets change the world. As an Automation Principal Engineer you will provide automation technical leadership to a group of Automation Engineers who are responsible to build and maintain various automation systems and platforms that support the GMP Drug Substance Plant Operations.
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust automation systems to operate the new plant. This includes complex and challenging system automation initiatives that require detailed understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.Responsibilities:
- Site construction, start-up, and operational readiness:
- Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), Building Management Systems (BMS), and Supervisory Control and Data Acquisition systems (SCADA).
- Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
- Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers or end-users to develop the best automation solutions.
- Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards.
- Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
- Build a robust talent pipeline with diverse capabilities. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure an ongoing organizational structure capable of adapting to evolving business needs. Establish technical training, leadership training, and cross-training plans to continually develop staff and build breadth and depth in the organization. Partner with staff to establish robust long-term development plans aligned with their aspirations and build robust succession plans through visibility to site, network, and external talent.
- Ongoing operations:
- Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
- Lead/support technical root cause analysis, incident investigations, and solving problems on process control issues related to plant operations.
- Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
- Manage Day-to-day Operational Support including: Automation System Administration, Automation System Operating Systems (OS) HotFix assessments and rollout, Preventative and corrective maintenance, and Automation System spare parts management
- Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.
What we expect of youBasic Qualifications:
Doctorate degree and 2 years of Manufacturing Automation Engineering experienceOr
Masters degree and 6 years of Manufacturing Automation Engineering experienceOr
Bachelors degree or and 8 years of Manufacturing Automation Engineering experienceOr
Associate degree and 10 years of Manufacturing Automation Engineering experienceOr
High school diploma / GED and 12 years of Manufacturing Automation Engineering experience
We are all different, yet we all use our unique contributions to serve patients. The Automation professional we seek has these qualifications:
- Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
- Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software.
- Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
- Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
- Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
- Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
- Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
- Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
- The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
- Strong leadership, technical writing, and communication/presentation skills.
What you can expect of us
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.
- 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.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 and Puerto Rico 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.