Manufacturing Systems Engineer: Automation (Swing Shift Monday - Friday)
About The Position
Join Amgen’s Mission of Serving Patients. Amgen is a global biotechnology company with a mission to serve patients living with serious illnesses. The company has pioneered the world of biotech and focuses on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Amgen is building its newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which will combine disposable technologies with traditional stainless-steel equipment for maximum flexibility. This facility will feature best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's plan to be a carbon-neutral company by 2027. The Manufacturing Systems Engineer, Automation will work with a group of automation engineers responsible for building and maintaining automation systems and platforms supporting GMP Drug Substance Plant Operations. The schedule for this position is Swing Shift, 3pm - 11pm, Monday through Friday. This role is part of the Facilities & Engineering (F&E) Automation team and will collaborate with the capital project team to deliver robust process automation systems for the new plant.
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
- 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.
Nice To Haves
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
Responsibilities
- 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.
Benefits
- A 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
