Senior Manufacturing Systems Engineer

Amgen Inc

Senior Manufacturing Systems Engineer role at Amgen's advanced biopharmaceutical manufacturing facility in North Carolina. The position focuses on designing and implementing automation solutions, managing capital projects, and supporting new product introductions within a GxP-regulated environment.

Responsibilities

Translate process requirements from subject matter experts into automated digital solutions
Lead functional area and capital projects integrating new drug substance manufacturing technologies
Support new product and technology introductions through automation engineering assessments and qualification
Develop process specifications, engineering policies, and GxP-compliant documentation
Evaluate and resolve project issues using technical, project management, and business expertise

Requirements

Doctorate degree OR Master's degree with 2+ years manufacturing process automation experience
Bachelor's degree with 4+ years manufacturing process automation/information systems experience
Pharma or biotech manufacturing environment experience
Emerson Delta-V DCS system design and implementation expertise
GAMP software development lifecycle and ANSI/ISA-S88/S95 standards knowledge
GMP biopharmaceutical equipment systems knowledge (bioreactors, chromatography, filtration)
Capital project lifecycle management experience

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Vacancy posted 6 days ago

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