Senior Manufacturing Systems Engineer - Amgen

Role Summary

Senior Manufacturing Systems Engineer at Amgen, supporting advanced drug substance manufacturing with industry 4.0 capabilities. Part of a technologically advanced facility focusing on integrating new technologies and automation to enhance manufacturing processes.

Responsibilities

• Work with process subject matter experts to translate key process requirements into digital automated solutions.
• Collaborate with business partners to identify how automation can improve workflow and productivity; synthesize requirements from clients/end-users to develop optimal automation solutions.
• Lead and support functional area projects and large capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead and support NPI or new technology introductions by performing automation assessments, implementing configuration changes, and supporting engineering and process qualification runs as applicable.
• Develop business processes aligned with project timelines; create detailed specifications and engineering policies affecting multiple units.
• Provide clear documentation for delivered solutions; work with QA to support computerized systems validation in a GxP environment.
• Anticipate, evaluate, and resolve project issues; manage multiple initiatives and priorities.
• Continuously explore innovative approaches to improve operations and cost efficiency.

Qualifications

• Basic Qualifications: Doctorate; or Master‚Äôs with 2 years of manufacturing process automation/information systems experience; or Bachelor‚Äôs with 4 years; or Associate‚Äôs with 8 years; or High school diploma/GED with 10 years.
• Preferred Qualifications: manufacturing environment experience in pharmaceutical/biotech; strong knowledge of automation design, process control engineering, GMP biopharma equipment/systems; extensive programming and lifecycle management of manufacturing process controls; experience with Emerson Delta-V DCS, PCN design, and VM infrastructure; knowledge of GAMP, ANSI/ISA-S88/S95; capital project lifecycle management; experience with process control strategies for NPI/NTE; hands-on coding with Emerson DeltaV, Rockwell FactoryTalk, Rockwell PLCs; Aveva PI Historian preferred; Kneat for C&Q a plus; strong leadership and communication skills.

Skills

• Process automation and information systems
• Automation design and process control engineering
• GxP/computerized systems validation
• Emerson Delta-V DCS, Rockwell PLCs, FactoryTalk
• Aveva PI Data Historian
• Kneat C&Q documentation
• Project management and cross-functional collaboration
• Technical writing and communication

Education

• Details provided under Basic Qualifications (doctorate or master/bachelor/associate/high school with corresponding experience).

Additional Requirements

• Travel requirements or physical demands not specified as essential in the source.