Digital Manufacturing Operations Specialist

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)