The Automation Lead will provide overall E2E Automation leadership to equipment and facility design of a new Drug Product (DP) aseptic manufacturing node, ensuring operational readiness and compliance with cGMP
Job Summary
The Automation Lead will provide overall E2E Automation leadership to equipment and facility design of a new Drug Product (DP) aseptic manufacturing node, ensuring operational readiness and compliance with cGMP.
Key responsibilities include leading the design and implementation of automation & OT systems, developing specifications, assessing vendor capabilities, and resolving technical issues during C&Q testing.
The role requires fostering a culture of technical excellence, collaboration, and innovation while maintaining GMP compliance and managing CAPAs.
Matching Summary
The Automation Lead will provide overall E2E Automation leadership to equipment and facility design of a new Drug Product (DP) aseptic manufacturing node, ensuring operational readiness and compliance with cGMP.
Skills & Requirements
Must-have
Automation and CSV deliverables
Process Automation Systems
Industrial Automation Networks
cGMP regulations
OSI PI Historian and Koerber MES
ISA S95 and S88 standards
Nice-to-have
Industry 4.0/IIoT appreciation
Talent Development
Organizational Leadership
Process knowledge for Drug Product
GAMP 5 methodologies
Key Requirements
Bachelor's degree in Engineering, Science or related field
Minimum 8 years of manufacturing experience
Minimum 2 years in Automation or IT role
Experience with Emerson DeltaV, OSI Pi, Siemens PLCs