Senior Manufacturing Systems Engineer DeltaV

In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, and drive innovation and support manufacturings upstream, downstream, and solution preparation automation needs.You will solve complex engineering problems and ensure the company’s engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

You will partner closely with the capital project team to design, build, commission, andqualifynew equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up, focusing on manufacturing automation.

Job responsibilities include:

• Site design, construction, start-up, and operational readiness:

• Provide support to the capital project team with a strong focus on safety and on-time facility start-up.

• Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarilyutilizingEmersonDeltaVDistributed Control System (DCS) forupstream, downstream, and/or solution prepoperations.

• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).

• Partner with various organizational units to support tasksincluding operational readiness, document reviews, deviationinvestigationand change controls.

• Develop andmaintaindetailed specifications,SOPsand operating standards thatimpactmultiple organizational units.

• Provide mentoring to develop and accelerate site technical automation capabilities.

• Site Operations:

• Act as system owner forUpstream,Downstream, and/or Solution prepAutomation processes.

• Manage 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, andAutomation Systemspare parts management

• Lead and support functional area projects focused on improving processequipment/utilities/facilitiesas well as capital projects to integrate new drug substance manufacturing technologies into the facility.

• Lead and support technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.

• Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchangesand supporting engineering and process qualification runs as applicable.

• Prepare and review Standard Operating Procedures (SOP) and cGMP documents., In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

• High School Diploma / GED and 10 years of Engineering experience OR
• Associates Degree and 8 years of Engineering experience OR
• Bachelors Degree and 4 years of Engineering experience OR
• Masters Degree and 2 years of Engineering experience OR
• Doctorate Degree

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science, ChemicalEngineeringorBiotech Engineering.

• Extensive experience with EmersonDeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.

• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.

• Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.

• Experiencewith upstream/downstream/solution prepunit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/diafiltrationamong others.

• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.

• In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.

• Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.

• 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.

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll 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., 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., We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.