SIEMENS OPCENTER MES ANALYST - USA

THE POSITION

The Siemens Opcenter MES Analyst will be responsible for the day-to-day functional and technical support, configuration, modelling, maintenance, and continuous improvement of the Siemens Opcenter Manufacturing Execution System.

This role will partner closely with Manufacturing, Quality, Engineering, Supply Chain, and IT teams to ensure the MES platform remains reliable, compliant, scalable, and aligned with manufacturing needs.

The analyst will serve as a key MES subject-matter expert, supporting existing manufacturing processes while designing, configuring, testing, and deploying new products, processes, workflows, integrations, and MES capabilities.

RESPONSIBILITIES:

MES Configuration & Modelling

• Configure and maintain Siemens Opcenter MES manufacturing models and workflows.

• Create and maintain product, process, routing, operation, resource, equipment, material, and related MES configurations.

• Configure electronic Device History Record (eDHR) processes and electronic manufacturing records.

• Configure data collection, operator instructions, process parameters, validations, exception handling, and electronic signatures.

• Configure manufacturing transactions, workflows, business rules, and user interfaces as required.

• Maintain reusable configuration and modelling standards to minimise unnecessary customisation.

• Perform impact analysis before implementing configuration or model changes.

Day-to-Day MES Support

• Provide Level 2/Level 3 support for Siemens Opcenter production issues.

• Troubleshoot manufacturing transactions, workflows, configuration, master data, integrations, and system errors.

• Support production users and resolve issues affecting manufacturing execution.

• Perform root-cause analysis for recurring MES incidents and implement sustainable corrective solutions.

• Monitor MES application health, interfaces, transaction failures, and production-impacting issues.

• Coordinate with infrastructure, database, integration, ERP, and vendor teams when issues cross system boundaries.

• Maintain support documentation, known-error information, and troubleshooting procedures.

New Products & Manufacturing Capabilities

• Partner with Manufacturing and Engineering to onboard new products and manufacturing processes into MES.

• Translate business and manufacturing requirements into scalable MES solutions.

• Configure new workflows, operations, data collection requirements, equipment, materials, and process controls.

• Evaluate opportunities to expand MES capabilities and reduce paper-based or manual manufacturing activities.

• Support manufacturing automation, shop-floor digitisation, genealogy, traceability, electronic work instructions, and data collection initiatives.

• Assess new Siemens Opcenter capabilities and recommend where they can provide business value.

ERP & Manufacturing System Integration

• Support integrations between Siemens Opcenter and ERP, labelling, equipment, automation, and other manufacturing applications.

• Troubleshoot interface errors and data synchronisation issues.

• Support transactions involving production/work orders, material consumption, inventory, confirmations, genealogy, and manufacturing status.

• Work with integration teams to ensure appropriate monitoring, error handling, and reprocessing capabilities.

• Support end-to-end testing when MES or connected applications change.

Validation & Regulatory Compliance

• Ensure MES solutions comply with applicable regulated manufacturing requirements and company procedures.

• Support 21 CFR Part 11, electronic records/electronic signatures, audit trail, security, and data integrity requirements.

• Support Computer Software Assurance/Computer System Validation activities as applicable.

• Participate in system risk assessments, requirements, design documentation, testing, and validation.

• Develop or support IQ/OQ/PQ, regression testing, and user acceptance testing as required.

• Ensure production changes follow approved SDLC and change-control procedures.

• Maintain appropriate traceability and documentation for system changes.

Release & Change Management

• Evaluate MES enhancement and change requests.

• Develop solution designs and estimates for approved changes.

• Configure and test changes in non-production environments before deployment.

• Coordinate MES releases across Development, Test/QA, Validation/UAT, and Production environments.

• Maintain configuration consistency and appropriate version control across environments.

• Develop deployment, rollback, and verification plans for production changes.

Continuous Improvement

• Identify opportunities to simplify MES configuration and improve system maintainability.

• Reduce recurring incidents through root-cause analysis and preventive improvements.

• Promote standard Siemens Opcenter capabilities before introducing custom solutions.

• Improve manufacturing user experience and reduce unnecessary operator interactions.

• Partner with business teams to identify opportunities for additional digitisation and automation.

• Support MES roadmap development and platform lifecycle planning.

TECHNICAL REQUIREMENTS:

• Bachelor's degree in Computer Science, Information Systems, Engineering, Manufacturing Engineering, or related discipline.

• 5–8 years of experience supporting manufacturing applications, with hands-on MES experience.

• 3+ years of hands-on experience with Siemens Opcenter preferred.

• Demonstrated experience configuring or modelling manufacturing processes within an MES.

• Understanding of:

  • Manufacturing orders and operations

  • Routings and workflows

  • BOM/material consumption

  • WIP management

  • Equipment and resources

  • Product genealogy and traceability

  • Electronic manufacturing records/eDHR

  • Data collection and process parameters

  • Exception and nonconformance processes

  • Experience troubleshooting MES production issues.

  • Experience with ERP-to-MES integration; SAP integration experience preferred.

  • Understanding of databases, SQL, APIs, interfaces, and integration concepts.

  • Experience working within formal SDLC and change-management processes.

Preferred Qualifications

• Siemens Opcenter Execution experience in a regulated manufacturing environment.

• Experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries.

• Experience with SAP manufacturing and inventory processes.

• Experience with Siemens Mendix and/or Opcenter user-interface technologies.

• Experience with manufacturing equipment and automation integration.

• Knowledge of ISA-95 manufacturing architecture principles.

• Experience with electronic DHR/electronic batch record solutions.

• Familiarity with labeling, barcode scanning, printers, scanners, and shop-floor devices.

• Experience with application monitoring and integration error-management tools.

• Familiarity with Power BI or other manufacturing analytics platforms.

Regulatory Knowledge

• Working knowledge of regulated computerised systems and manufacturing requirements, including:

• 21 CFR Part 11

• FDA Quality System requirements

• ISO 13485

• Data integrity and audit trails

• Electronic records and electronic signatures

• Computer System Validation / Computer Software Assurance

• Change control and SDLC

• Product genealogy and traceability

ABOUT YOU:

• Strategic, pragmatic, analytical, and technical thinking.

• Highly organised, ability to prioritise tasks and detail-oriented.

• Exceptional judgment, tact, and decision-making ability.

• Flexibility to adjust to multiple demands, shifting priorities, ambiguity, and rapid change.

• Outstanding management and interpersonal skills.

• Ability to work independently in a fast-paced, fluid environment.