Sterile GMP Automation Lead

WuXi AppTec; Town of Middletown (NY); Vor Ort; USD 120.000 - 190.000; Vollzeit

Zusammenfassung

WuXi AppTec is seeking an Automation Lead for our sterile manufacturing operations. You will serve as the primary automation SME, overseeing design, implementation, commissioning, qualification, and lifecycle management of automation and control systems supporting sterile manufacturing and GMP utilities.

You will lead cross-functional collaboration with Manufacturing, Quality, Validation, IT/OT, and Engineering to ensure compliance, reliability, and continuous improvement across the automation

Qualifikationen

• Bachelor’s or Master’s degree in Automation Engineering, Electrical Engineering, Control Engineering, Computer Engineering, or related technical discipline.
• Minimum of 5 years of experience in automation or controls engineering in pharma, biotech, or similarly regulated manufacturing.
• Hands-on experience with PLC, HMI, SCADA, DCS, historian systems, industrial networks, and troubleshooting.
• Experience with GMP utilities and pharmaceutical equipment automation preferred.
• Strong knowledge of cGMP, risk-based approaches, data integrity, FDA/EU regulatory expectations.

Aufgaben

• Serve as the primary automation SME for sterile manufacturing facilities and GMP utilities.
• Provide lifecycle support: design, FAT, SAT, commissioning, qualification, startup, operation, maintenance, and upgrades.
• Lead troubleshooting, root cause analysis, and corrective actions for automation failures.
• Collaborate with Manufacturing, Quality, Validation, IT/OT, and Engineering for system readiness and continuous improvement.
• Develop and maintain automation architectures, control strategies, and data management for assigned systems.
• Ensure compliance with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11) and company standards.

Kenntnisse

Automation engineering

PLC

HMI

SCADA

DCS

Root cause analysis

Regulatory compliance

Cybersecurity

Troubleshooting

Ausbildung

Bachelor's or Master's in Automation Engineering

Tools

EMS

Historian systems

Industrial networks

GMP utilities knowledge

Jobbeschreibung

WuXi AppTec is seeking an Automation Lead for our sterile manufacturing operations. You will serve as the primary automation SME, overseeing design, implementation, commissioning, qualification, and lifecycle management of automation and control systems supporting sterile manufacturing and GMP utilities.

You will lead cross-functional collaboration with Manufacturing, Quality, Validation, IT/OT, and Engineering to ensure compliance, reliability, and continuous improvement across the automation