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 smartmanufacturing initiatives focusing on end‑to‑end 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, 21CFR 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 Mendixapplications.
- Evaluate emerging Siemenscapabilities and industry trends (Industry 4.0, MES/MOM convergence, low‑codedevelopment, cloud-enabled platforms) and advise leadership on adoptionstrategy.
- Configure and manage business processes around materialmanagement/flow, equipment management including the electronic equipmentlogbook, and production record systems in Siemens Opcenter.
- Integrate SAP with Siemens Opcenter eBR and enableseamless communication to DCS (Distributed Control System) to support batchcreation via campaign management, process orchestration via Opcenter ConnectMOM, 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 complexintegrations between Siemens Opcenter / Mendix applications and DCS/SCADA/PLCsystems (e.g., DeltaV, PCS7), ERP platforms (SAP, including SAP MII/PI-PO),LIMS, warehouse management, and serialization/track‑and‑trace systems.
- Design and review advancedscripts, 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 ofjunior and mid‑level MES programmers/engineers, providing technical mentorship,code/configuration review, and knowledge transfer.
- Lead root‑cause analysis andresolution for the most complex, cross-system production issues and dataintegrity 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 activitiesfor significant MES configuration changes, including impact assessments, riskanalysis, and cross‑functional approval coordination.
Cross-Functional Collaboration & Strategy
- Partner with Manufacturing,Quality Assurance, Automation/OT, IT, and Validation leadership to support newproduct introductions, technology transfers, and site expansions.
- Act as primary technicalliaison 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 advancedtraining programs for engineering staff, operators, and quality personnel onMES functionality and best practices.
Required Qualifications
- Bachelor's degree in ComputerScience, Chemical Engineering, Electrical En