Lead Manufacturing Systems Engineer - IS/Automation

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

Amgen is seeking a Principal Manufacturing Systems Engineer to lead IS/Automation initiatives across a cutting-edge drug substance manufacturing plant. You will drive portfolio planning, risk management, and cross-functional collaboration to deliver advanced manufacturing solutions.

The role requires deep expertise in PCS/MES platforms, validation, and change control, with a focus on ensuring systems meet stringent industry standards.

Qualifications

• Doctorate or Master's or Bachelor's or Associate's or High school with extensive IS/automation experience.
• Experience in manufacturing environments and with PCS/MES systems.
• Experience with validation and change control methodologies.

Responsibilities

• Own the successful delivery of varied IS/Automation projects with portfolio planning, resource and risk management.
• Evaluate and resolve multiple project issues using technical, PM, and business expertise.
• Cross-system assessments, feasibility analysis, scope projects, prioritize work, and recommend solutions.
• Translate opportunities into executable plans aligned with standards and business needs.
• Manage relationships with IS service owners, business partners and vendors.
• Communicate issues and proposed solutions to multiple levels of the organization.
• Elicit and analyze business needs and convert them into functional design.

Skills

Leadership

Communication

Collaboration

Problem solving

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Emerson DeltaV

Rockwell FactoryTalk

Rockwell PLCs

Aveva PI Data Historian

Kneat C&Q

Korber MES

Job description

Amgen is seeking a Principal Manufacturing Systems Engineer to lead IS/Automation initiatives across a cutting-edge drug substance manufacturing plant. You will drive portfolio planning, risk management, and cross-functional collaboration to deliver advanced manufacturing solutions.

The role requires deep expertise in PCS/MES platforms, validation, and change control, with a focus on ensuring systems meet stringent industry standards.