Bilingual Digitalization Lead: ERP/MES for Pharma GMP

WuXi AppTec

Town of Middletown (NY)

Sur place

USD 130 000 - 185 000

Plein temps

14 jours+

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Résumé du poste

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.

Qualifications

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.

Responsabilités

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.