Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation

About the role

Amgen is hiring a Principal Manufacturing Systems Engineer for its new FleX Batch drug substance manufacturing plant, which combines disposable technologies with stainless steel equipment and includes Industry 4.0 and sustainability features. The engineer acts as a subject matter expert in automation engineering, influencing the design and implementation of automation systems for upstream and downstream bioprocessing, and works within the Facilities & Engineering group. The role partners with the corporate engineering team during design, build, commissioning and qualification, then supports daily operations for drug substance production.

Key responsibilities

• Support design reviews, commissioning and qualification of process equipment automation in line with GMP, and lead Automation IV/ACO activities
• Develop process control automation solutions mainly using Emerson DeltaV DCS, with the site process engineering team
• Provide 24x7 onsite/on-call support, troubleshooting and daily automation team meetings, and act as system owner for automation systems
• Support operational readiness, document reviews, deviation investigations and change controls, and perform automation change assessments
• Lead continuous improvement in safety, reliability, efficiency and sustainability, and maintain data integrity
• Mentor junior engineers and cross-functional teams, and influence automation strategy and standardization across the site and network
• Represent the plant in global automation forums, during audits and regulatory inspections, and stay current with emerging technologies

Required profile

• Basic qualifications: doctorate with 2 years of engineering experience, or master's with 4 years, or bachelor's with 6 years, or associate's with 10 years, or high school diploma with 12 years of engineering experience
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects or programs
• Work schedule flexibility for 24/7 operations, including occasional after-hours coverage
• Willingness to mentor staff and strong leadership, technical writing and communication skills

Required skills

• Emerson DeltaV and process control network design, including OPC, Foundation Fieldbus and Profibus
• Preferred: IO-Link, PAT tools, 21 CFR Part 11, GAMP, GDP, GMP and cGMP experience
• Preferred: tech transfer, process design, commissioning and qualification, and deep knowledge of upstream and downstream biopharmaceutical processes

Salary range: $160,327 to $216,913 USD. Up to 10% domestic or international travel.