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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
