Digitalization Lead, MES/ SAP

WuXi Chemistry; Town of Middletown (NY); On-site; USD 140,000 - 180,000; Full time

Job summary

WuXi Chemistry in Middletown, NY seeks a Digitalization Lead to drive the digital transformation roadmap for its manufacturing site, implementing ERP, LIMS, and MES with strong GMP validation and data integrity focus.

You will bridge local operations with global teams, managing budget, risks, and timelines while delivering scalable digital solutions compliant with FDA/EMA standards. Fluency in English and Chinese is required to coordinate across multinational teams.

Qualifications

• Bachelor’s/Master’s in Computer Science, IT, or related field.
• 5+ years of digital project management experience specifically within pharmaceutical manufacturing, biotech, or CDMO environment with deep knowledge of GMP/GxP.
• 3+ years of hands-on experience in large-scale ERP system implementations (e.g., SAP, Oracle), with a strong grasp of manufacturing and supply chain modules.
• Deep understanding of pharmaceutical regulatory frameworks, including Current Good Manufacturing Practices (cGMP), 21 CFR Part 11
• Proven organizational skills in managing cross-functional teams and vendors.
• Strong project management capability; PMP/Prince2 certification preferred.
• Native or professional fluency in English is required; Mandarin is a plus.
• Experience in multinational pharma or CDMO manufacturing sites preferred.
• Knowledge of drug discovery and pharmaceutical process development processes preferred.

Responsibilities

• Develop site digitalization roadmap, focusing on integration of ERP, LIMS, MES, etc.
• Lead & manage end-to-end ERP (e.g., SAP/Oracle) implementation, upgrade, and maintenance, ensuring pharmaceutical compliance.
• Lead & manage end-to-end manufacturing execution and operation management system (e.g., MES/WMS) implementation, upgrade, and maintenance, ensuring pharmaceutical compliance.
• Collaborate across IT, Manufacturing, Quality, and Supply Chain to organize resources for project management & execution.
• Ensure digital solutions comply with FDA/EMA data integrity principles (ALCOA+) and computer system validation (CSV) under GxP/GMP standards.
• Manage multiple projects with accountability for budget, timeline, risk mitigation, and milestone delivery.
• Establish project governance structures, reporting progress regularly to site leadership or steering committees.

Skills

Bilingual English-Chinese

ERP experience

CSV & FDA GMP compliance

Cross-functional leadership

Education

Bachelor’s/Master’s in Computer Science or IT

PMP/Prince2 certification

Tools

SAP

Oracle

LIMS

MES

WMS

Job description

Overview: We are seeking a high-energy, results-driven Digitalization Lead to spearhead the digital transformation roadmap at our Middletown manufacturing site. In this role, you will actively drive the end-to-end implementation, integration, and optimization of core enterprise and shop-floor systems, including ERP, LIMS, and MES. Serving as a critical bridge between local operations and global teams, you will deploy technical solutions that maximize operational efficiency while strictly maintaining FDA compliance, GMP validation, and data integrity standards. The ideal candidate brings a heavy blend of IT technical expertise and rigorous project management execution, backed by professional bilingual fluency in both English and Chinese to seamlessly coordinate across international boundaries.

Responsibilities

• Develop site digitalization roadmap, focusing on integration of ERP, LIMS, MES, etc.
• Lead & manage end-to-end ERP (e.g., SAP/Oracle) implementation, upgrade, and maintenance, ensuring pharmaceutical compliance.
• Lead & manage end-to-end manufacturing execution and operation management system (e.g., MES/WMS) implementation, upgrade, and maintenance, ensuring pharmaceutical compliance.
• Collaborate across IT, Manufacturing, Quality, and Supply Chain to organize resources for project management & execution.
• Ensure digital solutions comply with FDA/EMA data integrity principles (ALCOA+) and computer system validation (CSV) under GxP/GMP standards.
• Manage multiple projects with accountability for budget, timeline, risk mitigation, and milestone delivery.
• Establish project governance structures, reporting progress regularly to site leadership or steering committees.

Qualifications

• Bachelor’s/Master’s in Computer Science, IT, or related field.
• 5+ years of digital project management experience specifically within a pharmaceutical manufacturing, biotech, or CDMO environment with deep knowledge of GMP/GxP.
• 3+ years of hands-on experience in large-scale ERP system implementations (e.g., SAP, Oracle), with a strong grasp of manufacturing and supply chain modules.
• Deep understanding of pharmaceutical regulatory frameworks, including Current Good Manufacturing Practices (cGMP), 21 CFR Part 11
• Proven organizational skills in managing cross-functional teams and vendors.
• Strong project management capability; PMP/Prince2 certification preferred.
• Native or professional fluency in English is required; Mandarin is a plus, to effectively coordinate with global teams and stakeholders.
• Experience in multinational pharma or CDMO manufacturing sites preferred.
• Knowledge of drug discovery and pharmaceutical process development processes preferred.