Digital Manufacturing Operations Specialist

Datwyler
  • Middletown, OH
    30+ days ago

    Job Description

    In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

    Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

    Digital Manufacturing Operations Specialist

    Summary/Objective

    The Digital Manufacutring Operations Specialist is an experienced, hands-on SME responsible for supporting, optimizing, and continuously improving shop floor execution processes. The role serves as the primary (Key Super User bridge between Operations, Engineering, and IT to ensure digital applications effectively provide reliable, compliant, and efficient production and packaging execution. This position acts as the site subject matter expert for shop-floor systems, providing user support, troubleshooting, continuous improvement, and operational readiness while ensuring GMP compliance and data integrity. The role also supports cross-functional collaboration, real-time issue resolution, and adoption of standardized business processes across the manufacturing site.

    Key Responsibilities

    • Serve as the site Subject Matter Expert (SME) for system functionality, process execution, and continuous improvement
    • First point of contact for end users: Primary contact for operators; resolve issues or escalate to IT/Engineering
    • System user support: Guide correct use of MES/ERP/serialization systems (how to), providing hands-on support to manufacturing applications, including troubleshooting, root cause analysis, and real-time issue resolution
    • Process expert: Ensure consistent systems execution of production and packaging processes in line with standards
    • Analytics: Support real-time data flow, visibility, and analytics to enable insights that will improve production, quality, and release processes
    • OT coordination: Support issues involving equipment (PLC/SCADA) and system interfaces
    • Training: Deliver local training as part of train-the-trainer model from BPEs. Provide technical mentorship and guidance to junior team members and users
    • Change support: Participate in testing (UAT), rollout, and implementation of changes
    • Continuous improvement: Capture user feedback and support process improvements
    • Compliance: Ensure GMP adherence and data integrity

    Governance & Interface

    • BPO/BPE: Define global processes and train Key Users
    • Key User: Local trainer, first-line support, feedback provider
    • IT (Central): Owns and maintains systems
    • Engineering/Automation: Support equipment and OT

    Core Competencies

    • Knowledge of manufacturing and supply chain enterprise applications/systems
    • Strong shopfloor process knowledge (e.g., batch processing and/or discrete manufacturing)
    • Hands-on, problem-solving mindset
    • Strong communication and training skills
    • Ability to bridge Operations, IT, and Engineering
    • Ability to influence without authority and drive cross-functional alignment
    • Structured and compliance-focused

    Required Qualifications

    • Bachelor's degree in Engineering, IT, Life Sciences, or related field
    • 7-10 years of hands-on experience supporting and applications in a manufacturing environment
    • GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and regulatory requirements
    • Strong shopfloor process knowledge required, experience in pharma manufacturing/packaging preferred
    • Experience with MES/ERP systems (as user)
    • Hands-on OT understanding (PLC, SCADA, equipment interfaces)

    Key Success Factors

    • Ability to operate effectively as both a hands-on SME and a strategic thinker
    • Strong on-the-ground engagement with manufacturing teams to understand real-world execution
    • Strong user adoption and correct system usage
    • Clear and effective collaboration with BPEs and IT
    • High compliance and data integrity

    Be yourself at Datwyler

    We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

    www.datwyler.com

    Nearest Major Market: Philadelphia

    Numbers & Facts

    LocationMiddletown, OH
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    Skills

    • 1st Level Supportunmatched
    • Acceptance Testingunmatched
    • Automationunmatched
    • Biologyunmatched
    • Bridge Buildingunmatched
    • Business Processesunmatched
    • Civil Engineeringunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Computer Systemsunmatched
    • Congestive Heart Failureunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Customer Acquisitionunmatched
    • Customer Relationsunmatched
    • Customer Support/Serviceunmatched
    • Customer/Client Researchunmatched
    • Data Qualityunmatched
    • Discrete Manufacturingunmatched
    • Diversityunmatched
    • Drug Manufacturingunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Enterprise Applicationsunmatched
    • Food and Beverage Industryunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Healthcareunmatched
    • High Tech Industryunmatched
    • Identify Issuesunmatched
    • Information Technology & Information Systemsunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Execution Systems (MES)unmatched
    • Manufacturing Operationsunmatched
    • Manufacturing Softwareunmatched
    • Mentoringunmatched
    • Operational Improvementunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Process Manufacturingunmatched
    • Production Systemsunmatched
    • Programmable Logic Controller (PLC)unmatched
    • Quality Managementunmatched
    • Regulatory Requirementsunmatched
    • Revenue Growthunmatched
    • Root Cause Analysisunmatched
    • Salesunmatched
    • Software Administrationunmatched
    • Supervisory Control and Data Acquisition (SCADA)unmatched
    • Supply Chain Management Softwareunmatched
    • Support Documentationunmatched
    • Sustainabilityunmatched
    • System Validationunmatched
    • Systems Maintenanceunmatched
    • Training/Teachingunmatched

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