Bilingual Digitalization Lead: ERP/MES for Pharma GMP

WuXi AppTec; Town of Middletown (NY); Vor Ort; USD 130.000 - 185.000; Vollzeit

Zusammenfassung

WuXi AppTec in Middletown is seeking a Digitalization Lead to drive the digital transformation roadmap for the site, implementing and integrating ERP, LIMS, and MES while ensuring GMP/cGMP compliance and data integrity. The role coordinates with local operations and global teams to deliver scalable, quality-focused solutions.

You will lead cross-functional projects, manage budgets, timelines, and risk, and ensure successful validation and CSV practices under GxP.

Qualifikationen

• 5+ years of digital project management in pharma manufacturing or CDMO environments.
• Experience leading ERP (SAP/Oracle) implementations and upgrades with GMP/GxP compliance.
• Deep understanding of FDA/EMA data integrity, CSV, and 21 CFR Part 11.

Aufgaben

• Develop site digitalization roadmap focusing on ERP/LIMS/MES integration.
• Lead end-to-end ERP implementation, upgrade, and maintenance with pharmaceutical compliance.
• Lead end-to-end MES/WMS implementation, upgrade, and maintenance with pharmaceutical compliance.
• Collaborate with IT, Manufacturing, Quality, and Supply Chain to organize resources for projects.
• Ensure digital solutions comply with FDA/EMA data integrity principles and CSV under GxP/GMP.
• Manage multiple projects with budgets, timelines, risk mitigation, and milestones.
• Establish project governance and regularly report progress to site leadership.

Kenntnisse

Project management

Cross-functional collaboration

Bilingual English/Chinese

Ausbildung

Bachelor's degree in Computer Science / IT

Master's degree (preferred)

Tools

SAP

Oracle

LIMS

MES

Jobbeschreibung

WuXi AppTec in Middletown is seeking a Digitalization Lead to drive the digital transformation roadmap for the site, implementing and integrating ERP, LIMS, and MES while ensuring GMP/cGMP compliance and data integrity. The role coordinates with local operations and global teams to deliver scalable, quality-focused solutions.

You will lead cross-functional projects, manage budgets, timelines, and risk, and ensure successful validation and CSV practices under GxP.