Career Category
Manufacturing
Job Description
Join Amgenâs Mission of Serving Patients
At Amgen, if you feel like youâre part of something bigger, itâs because you are. Our shared missionâto serve patients living with serious illnessesâdrives all that we do.
Since 1980, weâve helped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas âOncology, Inflammation, General Medicine, and Rare Diseaseâ we reach millions of patients each year. As a member of the Amgen team, youâll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youâll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Principal Engineer: Automation
What you will do
Letâs do this. Letâs 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 sophisticated and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.
- Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), and Building Management Systems (BMS).
- 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.
- Provide rotational automation on-call support for manufacturing operations.
- Maintain detailed specification and engineering policies and procedures that affect multiple organizational units.
- Assist in the cultivation of a robust talent pipeline with diverse capabilities required to thrive in the present and future based on perception of team needs. Partner with the Sr. Manager and HR to recruit, coach, develop, empower, 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.
- Act as an expert resource for helping fellow automation engineering staff to build out robust long-term development plans aligned with their aspirations.
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 troubleshooting 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.
- Provide 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 you
We are all different, yet we all use our unique contributions to serve patients. The Automation professional we seek has these qualifications.
Basic Qualifications:
- High school diploma / GED and 12 years of Manufacturing Automation Engineering experience OR
- Associate degree and 10 years of Manufacturing Automation Engineering experience OR
- Bachelorâs degree or and 6 years of Manufacturing Automation Engineering experience OR
- Masterâs degree and 4 years of Manufacturing Automation Engineering experience OR
- Doctorate degree and 2 years of Manufacturing Automation Engineering experience
Preferred Qualifications:
- Degree in Electrical Engineering, 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, 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 sophisticated troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
- A degree of high-level experience with standalone PLC systems and/or Siemens Desigo BAS is not a requirement, but would be beneficial to the role.
- 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 implementation.
- Hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
- 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 standout colleague 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, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, weâll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team!
careers.amgen.com
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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 c