1 day ago
Singapore, SingaporeStaff+
Responsibilities
- Serve as senior technical authority and architect for Aspen MES and Aspen InfoPlus.21 solutions across manufacturing sites.
- Lead design and configuration of electronic batch records, recipe structures, equipment models, and unit procedures.
- Own MES platform roadmaps, upgrade strategies, capacity planning, and long-term architecture decisions.
- Lead full lifecycle MES implementations from requirements and design through configuration, integration, testing, validation, and go-live.
- Architect integrations with DCS, SCADA, PLC, ERP, LIMS, warehouse management, and serialization systems.
- Design and review scripts, calculations, custom reports, and platform extensions.
- Direct, mentor, and review the work of junior and mid-level MES programmers and engineers.
- Lead root-cause analysis for complex cross-system production issues and data integrity discrepancies.
- Own computer system validation strategy and related URS, FS, DS, and IQ/OQ/PQ documentation.
- Ensure compliance with 21 CFR Part 11, GMP, GAMP 5, and ALCOA+ data integrity principles.
- Represent MES technical matters in audits, regulatory inspections, and quality reviews.
- Lead change control, impact assessments, risk analysis, and cross-functional approvals.
- Partner with manufacturing, quality, automation/OT, IT, and validation leaders on product introductions, technology transfers, and site expansions.
- Coordinate with AspenTech or implementation partners on escalations, licensing, upgrades, and roadmap alignment.
- Develop and deliver advanced MES training for engineering, operations, and quality personnel.
Requirements
- 15+ years of hands-on experience developing, architecting, and supporting AspenTech MES in regulated pharmaceutical, biotech, or life sciences manufacturing.
- Experience leading full-cycle MES implementations, including greenfield deployments and multi-site rollouts.
- Deep expertise in electronic batch records, recipe and procedure modeling, and complex production workflow configuration.
- Advanced proficiency with SQL and relational databases including SQL Server and Oracle.
- Strong knowledge of PLC, SCADA, DCS, and OT/IT integration architecture.
- Expert understanding of GMP, 21 CFR Part 11, GAMP 5, and computer system validation methodology.
- Experience managing MES change control, deviation investigations, and CAPA.
- Ability to mentor technical teams and communicate with senior leadership, quality, and regulatory stakeholders.
- Experience with Aspen PEM, Aspen Enterprise Historian, or the broader AspenTech MOM suite is preferred.
- Experience architecting enterprise-scale MES-to-ERP integrations using SAP MII, PI/PO, or equivalent middleware is preferred.
- Advanced scripting or programming experience with VB.NET, C#, or Python is preferred.
- Experience in sterile or aseptic processing, biologics, solid dose, or combination product manufacturing is preferred.
- Working knowledge of ISA-95 and ISA-88 is preferred.
- Experience leading serialization and track-and-trace integrations is preferred.
- ISPE/GAMP certification, PMP, or equivalent professional certification is preferred.
- Prior experience as a technical lead, principal engineer, or MES architect is preferred.
About Cognizant
Cognizant is a public IT services and consulting firm that designs, builds, and runs enterprise technology, including digital engineering, cloud modernization, data/AI, and managed services. It sells consulting, systems integration, and outsourcing on multi-year engagements to large enterprises in healthcare, banking, retail, communications, and manufacturing. Founded in 1994 and headquartered in Teaneck, New Jersey, Cognizant is NASDAQ-listed (CTSH) and a Fortune 500 company.