Job Summary

We are looking for an experienced Senior Siemens MES Programmer with 10+ years of practical experience in Siemens Opcenter and Mendix, delivering and maintaining Siemens Manufacturing Execution System (MES) solutions for regulated pharmaceutical manufacturing environments. This is a senior technical and advisory position for a professional who has led end-to-end MES implementations, mentored junior engineers, and acted as the primary subject matter expert for Siemens Opcenter MES architecture, integration, and validation strategy. Drive smartmanufacturing initiatives with end‑to‑end integration of manufacturing execution systems (MES), SAP, and DCS through Opcenter Connect MOM. The ideal candidate will combine deep technical expertise in Siemens Opcenter Execution and the Siemens MES/MOM portfolio with Mendix low-code application development, along with strong leadership capability—serving as a technical lead on multi-site programs, greenfield deployments, and enterprise-level system upgrades—while maintaining full compliance with GxP, 21CFR Part 11, and data integrity requirements.

KeyResponsibilities

Technical Leadership &Architecture

. Act as the senior technical authority and architect for Siemens Opcenter and Mendix MES solutions across one or more manufacturing sites, establishing system architecture, standards, and best practices.

. Lead the design and configuration of high-complexity electronic batch records (EBRs), recipe management structures, equipment models, and unit procedures for multi-product or advanced 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 Mendixapplications.

. Assess emerging Siemens capabilities and industry developments (Industry 4.0, MES/MOM convergence, low-codedevelopment, cloud-enabled platforms) and advise leadership on adoptionstrategy.

. Configure and manage business processes for materialmanagement/flow, equipment management (including the electronic equipmentlogbook), and production record systems within Siemens Opcenter.

. Integrate SAP with Siemens Opcenter eBR and enable reliable communication to DCS (Distributed Control System) to support batch creation through campaign management, process orchestration via Opcenter ConnectMOM, and batch data capture into the electronic production record.

. Lead smart manufacturing projects

Development, Integration &Delivery

. Lead full lifecycle delivery for large-scale MES programs: requirements definition, functional/technical design, configuration, custom scripting, integration, testing, validation, and go-live support.

. Architect and oversee advanced integrations between Siemens Opcenter / Mendix applications and DCS/SCADA/PLCsystems (e.g., DeltaV, PCS7), as well as ERP solutions (SAP including SAP MII/PI-PO), LIMS, warehouse management, and serialization/track-and-trace systems.

. Create and review advancedscripts, calculations, and custom reports using Opcenter scripting tools, Mendix microflows, SQL, and supporting languages (VB.NET, C#, Java, JavaScript,Python) to enhance platform functionality.

. Direct and review the work ofjunior and mid-level MES programmers/engineers, delivering technical mentorship, performing code/configuration reviews, and ensuring knowledge transfer.

. Lead root-cause assessment andresolution for the most complex, cross-system production issues and data integrity discrepancies, reducing manufacturing downtime.

Quality, Compliance &Validation

. Own and implement computer system validation (CSV) strategy for MES projects in alignment with GAMP 5, authoring and approving URS, FS, DS, and IQ/OQ/PQ documentation.

. Ensure all MES architecture, configuration, and development efforts comply with 21 CFR Part 11, GMP, and data integrity (ALCOA+) principles.

. Act as the senior MES representative during audits, regulatory inspections, and internal quality reviews, providing technical rationale and remediation plans when required.

. Lead change control processesfor material MES configuration updates, including impact assessments, risk analysis, and coordination of cross-functional approvals.

Cross-Functional Collaboration& Strategy

. Collaborate with Manufacturing,Quality Assurance, Automation/OT, IT, and Validation leadership to enable newproduct introductions, technology transfers, and site expansions.

. Serve as the primary technicalliaison with Siemens (or implementation partners) for escalations, licensing,upgrade planning, and roadmap alignment.

. Share technical strategies,risk evaluations, and project status with senior management and key stakeholders.

. Create and deliver advancedtraining for engineering staff, operators, and quality teams onMES functionality and best practices.

RequiredQualifications

. Bachelor's degree in ComputerScience, 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 OpcenterMES (Opcenter Execution Pharma / Opcenter Execution Foundation) and Mendixapplications within regulated pharmaceutical, biotech, or life sciences manufacturingenvironments.

. Proven experience leading end-to-end MES implementations, including greenfield deployments and multi-siterollouts.

. Extensive expertise in electronicbatch record (EBR) design, recipe/procedure modeling, and complex productionworkflow configuration.

. Advanced capability with SQL andrelational databases (SQL Server, Oracle) to support data architecture, reporting, and troubleshooting.

. Strong understanding of automation/control systems (PLC, SCADA, DCS) and OT/IT integration architecture.

. Expert-level knowledge of GMP, 21 CFR Part 11, GAMP 5, and computer system validation (CSV) methodology, with demonstrated success leading validation activities.

. Demonstrated background managing change control, deviation investigations, and CAPA initiatives connected to MES systems.

. Ability to mentorand lead technical teams, and to communicate effectively with seniorleadership, quality, and regulatory stakeholders.

. Exceptional analytical, troubleshooting, and decision-making skills for complex, multi-system, business-critical challenges.

Preferred Qualifications

. Experience using Opcenter Intelligence, Opcenter Connect MOM, Siemens Insights Hub, or other components of the Siemens Manufacturing Operations Management (MOM) portfolio.

. Experience designingMES-to-ERP integrations (SAP MII, PI/PO, or equivalent middleware) at anenterprise level.

. Advanced scripting/programmingexpertise in VB.NET, C#, or Python for platform extension and automation.

. Experience in sterile/asepticprocessing, biologics, solid dose, or combination product manufacturing.

. Working knowledge of ISA-95 /ISA-88 standards and applying them in enterprise MES architecture.

. Experience leadingserialization/track-and-trace integration efforts.

. ISPE / GAMP certification, PMP,Mendix Advanced/Expert Developer certification, or equivalent professionalcertification.

. Prior experience in a technicallead, principal engineer, or MES architect role.

Key Competencies

. Strategic thinking with theability to convert business and regulatory requirements into scalabletechnical architecture.

. Strong leadership, mentoring,and stakeholder engagement capabilities.

. High attention to detail and commitment to data integrity and data quality compliance.

. Excellent written and verbalcommunication skills, including experience presenting to senior leadership andregulatory bodies.

. Solid judgment and professionalismwhen leading the resolution of business-critical production issues.

. Expert knowledge onSiemens Opcenter architecture and MES modules such as Opcenter Execution Pharma,Opcenter Execution Foundation, Opcenter Connect MOM, and Opcenter Intelligence,along with Mendix platform architecture (domain models, microflows, and mobile/shop-floorapplications).

. Extensive hands-onexperience with the Opcenter Execution Pharma eBR application—creating master batchrecords and recipes, including SQL and Mendix microflow logic—to enable generic designs that support multiple business processes and electronic production record management.

. Expert knowledge onmaster batch record (MBR), recipe, and work instruction design aligned tobusiness process requirements.

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