Senior Manufacturing Systems Engineer - Amgen

Role Summary

Senior Manufacturing Systems Engineer at Amgen focusing on integrating advanced automation and Industry 4.0 capabilities within a leading drug substance manufacturing facility. WillCollaborate with SMEs, drive digital automation solutions, and support large-scale capital projects and new product introductions.

Responsibilities

• Work with process subject matter experts to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how automation can improve workflow and productivity; synthesize requirements from clients, customers or end-users to develop the best automation solutions.
• Lead and support functional area projects to improve process equipment/utilities/facilities and to integrate new drug substance manufacturing technologies; support large/sophisticated capital projects.
• Lead and support new product introductions or new technology introductions via automation engineering assessments, configuration changes, and process qualification support.
• Build business processes to support project scope; develop detailed specifications and engineering policies/procedures affecting multiple units.
• Provide documentation for delivered solutions; work with QA and support computerized systems validation in a GxP environment.
• Anticipate, evaluate, and resolve project issues; manage multiple initiatives and priorities.
• Continuously explore new technologies and cost-effective processes.

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/GED with 10 years.
• Preferred Qualifications: Manufacturing environment experience in Pharmaceutical/Biotech; automation design and process control engineering experience with GMP facilities; programming, design, installation, and lifecycle management of manufacturing process controls and instrumentation; experience with Emerson DeltaV, Rockwell interfaces, Aveva PI, and related standards; knowledge of GAMP, ISA-S88/S95; capital project lifecycle management; hands-on experience with NPI/NTD for Drug Substance; strong coding experience with DeltaV, Rockwell, and PI Historian; Kneat C&Q documentation knowledge is a plus; leadership and collaborative skills.

Skills

• Automation design and process control engineering
• GxP/computerized systems validation
• Project management and cross-functional collaboration
• Strong technical writing and communication

Education

• Doctorate or Master‚Äôs with experience; or Bachelor‚Äôs with experience; or Associate‚Äôs with experience; or High School/GED with extensive experience as listed in Basic Qualifications.