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Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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 lie within them, you’ll 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch 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.
Job Responsibility:
Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS)
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Provide clear documentation for delivered solutions and processes
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment
Own and drive to completion Change Controls, CAPAs, and Deviations
Support technical root cause analysis, incident investigations, and troubleshooting
Support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
Support day-to-day operations including rotational on-call support
Prepare/review Standard Operating Procedures (SOP) and cGMP documents
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
Requirements:
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
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
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, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software
Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies
Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus 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
Self-directed team player able to work cross-functionally
Strong technical writing and communication skills
What we offer:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible