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.