Sterile GMP Automation Lead
WuXi AppTec Group
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Job summary
The WuXi AppTec Group is seeking an Automation Lead for our sterile manufacturing facility to own automation and control systems lifecycle. You will design, implement, commission, qualify, maintain, and continuously improve GMP automation across WFI, EMS, and utility systems, working with IT/OT and Manufacturing teams.
You will guide engineering staff, drive reliability and compliance with cGMP, FDA/cGMP standards, and global regulatory expectations, ensuring robust cybersecurity and quality
Qualifications
- Minimum 5 years in automation or controls engineering in pharma or regulated manufacturing.
- Experience with GMP computerized systems lifecycle: FAT, SAT, qualification, start-up.
- Strong documentation skills and familiarity with FDA 21 CFR Part 11 and EU Annex 11.
Responsibilities
- Serve as the automation SME for the sterile manufacturing facility and related GMP utilities.
- Provide technical oversight across design, FAT, SAT, commissioning, and lifecycle management.
- Lead troubleshooting, RCAs, and continuous improvement of automation systems.
- Support tech transfer, scale-up activities, and cross-functional collaboration with IT/OT, Quality, and Manufacturing.
- Develop and maintain automation standards, procedures, and training materials.
Skills
Education
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Job description
The WuXi AppTec Group is seeking an Automation Lead for our sterile manufacturing facility to own automation and control systems lifecycle. You will design, implement, commission, qualify, maintain, and continuously improve GMP automation across WFI, EMS, and utility systems, working with IT/OT and Manufacturing teams.
You will guide engineering staff, drive reliability and compliance with cGMP, FDA/cGMP standards, and global regulatory expectations, ensuring robust cybersecurity and quality
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