Senior Manufacturing Systems Lead, Digital Transformation

Amgen; Juncos (PR); On-site; USD 140,000 - 180,000; Full time

Job summary

Amgen is seeking a Sr. Systems Engineer - Project Delivery Lead to drive digital transformation of manufacturing systems.

You will lead MES, SCADA, Industry 4.0 initiatives, ensuring alignment with cGMP and data integrity while coordinating with IT and vendor teams. In this role, you’ll develop system requirements, design specs, test plans, and validation activities, and mentor staff through audits and inspections.

Qualifications

• Doctorate in Engineering, or Master’s with 2+ years manufacturing systems/automation experience, or Bachelor’s with 4+ years in the field.
• Experience in pharmaceutical/biotech processes, especially inspection or packaging operations.
• Strong organizational, project management and problem-solving abilities.
• Knowledge of data integrity and cybersecurity concepts.

Responsibilities

• Lead the digital transformation of manufacturing systems, including MES/SCADA and Industry 4.0 initiatives.
• Develop system requirements, design specifications, test plans, and validation documentation.
• Coordinate commissioning, qualification, validation, and change control activities.
• Train users and support audits/inspections, ensuring cGMP compliance.

Skills

Cross-functional leadership

Teamwork & communication

Regulated manufacturing experience

Problem solving

Adaptability

Lean/Operational Excellence

Education

Doctorate in Engineering

Master’s in Engineering + 2 yrs Manufacturing Systems/Automation

Bachelor’s in Engineering + 4 yrs Manufacturing Systems/Automation

Tools

Rockwell Automation

Cognex Machine Vision

Systech Guardian/Advisor/Sentri

Databases

GAMP/GMP documentation

Job description

Amgen is seeking a Sr. Systems Engineer - Project Delivery Lead to drive digital transformation of manufacturing systems.

You will lead MES, SCADA, Industry 4.0 initiatives, ensuring alignment with cGMP and data integrity while coordinating with IT and vendor teams. In this role, you’ll develop system requirements, design specs, test plans, and validation activities, and mentor staff through audits and inspections.