Senior Siemens MES Programmer (Opcenter & Mendix)

Job Summary

We are seeking a seasoned Senior Siemens MES Programmer with 10+ years of hands-on experience in Siemens Opcenter and Mendix designing, building, and supporting Siemens 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 Siemens Opcenter MES architecture, integration, and validation strategy. Drive smart manufacturing initiatives focusing on endtoend integration of manufacturing execution systems (MES), SAP, and DCS via Opcenter Connect MOM. The successful candidate will combine deep technical mastery of Siemens Opcenter Execution and the Siemens MES/MOM portfolio, together with Mendix low-code application development, 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 Siemens Opcenter and Mendix MES 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 Siemens Opcenter portfolio (Opcenter Execution Pharma, Opcenter Connect MOM, Opcenter Intelligence) and Mendix applications.

• Evaluate emerging Siemens capabilities and industry trends (Industry 4.0, MES/MOM convergence, low-code development, cloud-enabled platforms) and advise leadership on adoption strategy.

• Configure and manage business processes around material management/flow, equipment management including the electronic equipment logbook, and production record systems in Siemens Opcenter.

• Integrate SAP with Siemens Opcenter eBR and enable seamless communication to DCS (Distributed Control System) to support batch creation via campaign management, process orchestration via Opcenter Connect MOM, and batch data recording into the electronic production record.

• Lead smart manufacturing projects

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 Siemens Opcenter / Mendix applications 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 Opcenter scripting tools, Mendix microflows, SQL, and supporting languages (VB.NET, C#, Java, JavaScript, 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 Siemens (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

• Bachelor's degree in Computer Science, Chemical Engineering, Electrical Engineering, Information Technology, or a related field (or equivalent extensive experience).

• 10+ years of progressive, hands-on experience developing, architecting, and supporting Siemens Opcenter MES (Opcenter Execution Pharma / Opcenter Execution Foundation) and Mendix applications 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 Opcenter Intelligence, Opcenter Connect MOM, Siemens Insights Hub, or the broader Siemens Manufacturing Operations Management (MOM) portfolio.

• 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, Mendix Advanced/Expert Developer certification, or equivalent professional certification.

• Prior experience in a technical lead, principal engineer, or MES architect role.

Key Competencies

• Strategic thinking with the ability to translate business and regulatory requirements into scalable technical architecture.

• Strong leadership, mentoring, and stakeholder management skills.

• Uncompromising attention to detail and commitment to data integrity and quality compliance.

• Excellent verbal and written communication skills, including experience presenting to senior leadership and regulatory bodies.

• Sound judgment and composure when leading resolution of business-critical production issues.

• Expert knowledge on Siemens Opcenter architecture and MES modules like Opcenter Execution Pharma, Opcenter Execution Foundation, Opcenter Connect MOM, and Opcenter Intelligence, plus Mendix platform architecture (domain models, microflows, and mobile/shop-floor applications).

• Extensive experience with the Opcenter Execution Pharma eBR application – designing master batch records and recipes, including SQL and Mendix microflow logic, to allow generic designs that work for multiple business processes and production record management.

• Expert knowledge on master batch record (MBR), recipe, and work instruction design for the business process requirements.

• Strong knowledge of material management, equipment management, and master data management (MDM) configuration.

Work Environment

This role may require time on the manufacturing floor within a GMP-regulated pharmaceutical production environment, in addition to office/IT-based work. As a senior technical leader, some off-hours availability may be required to support critical production issues, planned outages, or major system upgrades, along with occasional travel to support multi-site programs.