Job Summary
We are seeking a seasoned Senior Aspen MES Programmer with 15+ years of hands-on experience designing, building, and supporting AspenTech Manufacturing Execution System (MES) solutions in regulated pharmaceutical manufacturing environments. This is a senior technical and advisory role for an individual who has led complex MES implementations end-to-end, mentored junior engineers, and served as the go-to subject matter expert for Aspen MES architecture, integration, and validation strategy. The successful candidate will combine deep technical mastery of Aspen InfoPlus.21 and the AspenTech MES/MOM suite with strong leadership skills, acting as a technical lead on multi-site programs, greenfield implementations, and enterprise-level system upgrades, while ensuring full compliance with GxP, 21 CFR Part 11, and data integrity requirements.
Key Responsibilities
Technical Leadership & Architecture
Serve as the senior technical authority and architect for Aspen MES / Aspen InfoPlus.21 (IP.21) solutions across one or more manufacturing sites, defining system architecture, standards, and best practices.
Lead the design and configuration of complex electronic batch records (EBRs), recipe management structures, equipment models, and unit procedures for high-complexity or multi-product manufacturing lines.
Own the technical roadmap for MES platform evolution, including upgrade strategy, capacity planning, and long-term architecture decisions across the Aspen MOM/MES suite (Aspen MES, Aspen PEM, Aspen Enterprise Historian).
Evaluate emerging AspenTech capabilities and industry trends (Industry 4.0, MES/MOM convergence, cloud-enabled historians) and advise leadership on adoption strategy.
Development, Integration & Delivery
Lead full lifecycle delivery of large-scale MES projects: requirements definition, functional/technical design, configuration, custom scripting, integration, testing, validation, and go-live support.
Architect and oversee complex integrations between Aspen MES and DCS/SCADA/PLC systems (e.g., DeltaV, PCS7), ERP platforms (SAP, including SAP MII/PI-PO), LIMS, warehouse management, and serialization/track-and-trace systems.
Design and review advanced scripts, calculations, and custom reports using Aspen MES scripting tools, SQL, and supporting languages (VB.NET, C#, Python) to extend platform capability.
Direct and review the work of junior and mid-level MES programmers/engineers, providing technical mentorship, code/configuration review, and knowledge transfer.
Lead root-cause analysis and resolution for the most complex, cross-system production issues and data integrity discrepancies, minimizing manufacturing downtime.
Quality, Compliance & Validation
Own and drive computer system validation (CSV) strategy for MES projects in accordance with GAMP 5, authoring and approving URS, FS, DS, and IQ/OQ/PQ documentation.
Ensure all MES architecture, configuration, and development activities comply with 21 CFR Part 11, GMP, and data integrity (ALCOA+) principles.
Serve as the senior MES representative in audits, regulatory inspections, and internal quality reviews, providing technical justification and remediation plans as needed.
Lead change control activities for significant MES configuration changes, including impact assessments, risk analysis, and cross-functional approval coordination.
Cross-Functional Collaboration & Strategy
Partner with Manufacturing, Quality Assurance, Automation/OT, IT, and Validation leadership to support new product introductions, technology transfers, and site expansions.
Act as primary technical liaison with AspenTech (or implementation partners) for escalations, licensing, upgrade planning, and roadmap alignment.
Present technical strategies, risk assessments, and project status to senior management and stakeholders.
Develop and deliver advanced training programs for engineering staff, operators, and quality personnel on MES functionality and best practices.
Required Qualifications
15+ years of progressive, hands-on experience developing, architecting, and supporting AspenTech MES (Aspen MES / Aspen InfoPlus.21 / Aspen Production Execution Manager) within regulated pharmaceutical, biotech, or life sciences manufacturing environments.
Demonstrated experience leading full-cycle MES implementations, including greenfield deployments and multi-site rollouts.
Deep expertise in electronic batch record (EBR) design, recipe/procedure modeling, and complex production workflow configuration.
Advanced proficiency in SQL and relational databases (SQL Server, Oracle) for data architecture, reporting, and troubleshooting.
Strong working knowledge of automation/control systems (PLC, SCADA, DCS) and OT/IT integration architecture.
Expert-level understanding of GMP, 21 CFR Part 11, GAMP 5, and computer system validation (CSV) methodology, with a track record of leading validation efforts.
Proven experience managing change control, deviation investigations, and CAPA related to MES systems.
Demonstrated ability to mentor and lead technical teams, and to communicate effectively with senior leadership, quality, and regulatory stakeholders.
Exceptional analytical, troubleshooting, and decision-making skills for complex, multi-system, business-critical issues.
Preferred Qualifications
Experience with Aspen Production Execution Manager (PEM), Aspen Enterprise Historian, or the broader AspenTech Manufacturing Operations Management (MOM) suite.
Experience architecting MES-to-ERP integrations (SAP MII, PI/PO, or equivalent middleware) at an enterprise scale.
Advanced scripting/programming experience in VB.NET, C#, or Python for platform extension and automation.
Experience in sterile/aseptic processing, biologics, solid dose, or combination product manufacturing.
Working knowledge of ISA-95 / ISA-88 standards and their application in enterprise MES architecture.
Experience leading serialization/track-and-trace integration initiatives.
ISPE / GAMP certification, PMP, or equivalent professional certification.
Prior experience in a technical lead, principal engineer, or MES architect role.
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コグニザントについて
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