Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream

Us - North Carolina - Holly Springssenior

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Requirements Summary

Site design, construction, start-up, and operational readiness: Build and lead a team of Automation engineering professionals and serve as the ma

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Engineering

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 lay 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 Amgen FleX batch facility will combine the latest in single use 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.

Responsibilities

~2 min read

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Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering.

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

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Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments.

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Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing.

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

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

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Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation

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Experience with Tech Transfer, Process Design, and Commissioning & Qualification.

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Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.

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Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.