Job Information
Amgen Automation Engineer - Upstream Delta V in Holly Springs, North Carolina
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most sophisticated 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.
Automation Engineer - Upstream Delta V
Live!
What you will do
Let’s do this. Let’s change the world. In this vital role 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 complicated 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.
Site construction, start-up, and operational readiness:
Develop and maintain Process control automation solutions on Emerson DeltaV Distributed Control system (DCS).
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 automation can improve workflow and efficiency. 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.
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast paced environment.
Ongoing operations:
Lead and support functional area projects passionate about 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 utilities and building control
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.
Lead Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, Preventative and corrective maintenance, system administration, 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 efficiently.
Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
Win!
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.
Basic Qualifications:
High School Diploma / GED and 8 years of Engineering experience OR
Associate’s Degree and 6 years of Engineering experience OR
Bachelor’s Degree and 2 years of Engineering experience OR
Master’s Degree
Preferred Qualifications:
Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors 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 DeltaV-DCS system, Process Control Network design including network segregation, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is preferred.
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, case development, detailed design, engineering and validation documentation and project execution.
Proven hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
Proven experience with continuous improvements resulting in enhanced safety, system reliability, and efficiency (e.g., cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
The ideal individual must be a self-directed teammate ready to accept a team-based culture that relies on collaboration for effective decision-making.
Strong leadership, technical writing, and communication/presentation skills.
Thrive
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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your 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.