Digital Manufacturing Operations Specialist

Summary / Objective

The Digital Manufacturing Operations Specialist is an experienced, hands-on subject matter expert (SME) responsible for supporting, optimizing, and continuously improving shop floor execution processes. This role serves as a key super user and bridge between Operations, Engineering, and IT, ensuring digital applications deliver reliable, compliant, and efficient production and packaging execution.

This position acts as the site expert for shop-floor systems, providing user support, troubleshooting, continuous improvement, and operational readiness, while maintaining 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

• Subject Matter Expertise Serve as the site SME for system functionality, process execution, and continuous improvement initiatives.
• End User Support Act as the primary point of contact for operators, resolving issues or escalating to IT/Engineering as needed.
• System Support & Troubleshooting Provide hands-on support for manufacturing systems (MES, ERP, serialization), including troubleshooting, root cause analysis, and real-time issue resolution.
• Process Execution Ensure consistent and compliant execution of production and packaging processes aligned with established standards.
• Data & Analytics Support real-time data flow, system visibility, and analytics to drive improvements in production, quality, and release processes.
• Operations Technology (OT) Coordination Assist with issues related to equipment integration and interfaces, including PLC and SCADA systems.
• Training & Mentorship Deliver local training using a train-the-trainer model and provide technical guidance to users and junior team members.
• Change Management Support system updates through user acceptance testing (UAT), rollout, and implementation.
• Continuous Improvement Capture user feedback and contribute to process and system enhancements.
• Compliance & Data Integrity Ensure adherence to GMP standards and maintain data integrity across systems.
  
  

Governance & Interfaces

• Business Process Owners (BPO/BPE): Define global processes and train key users
• Key User (This Role): Local trainer, first-line support, and feedback provider
• IT (Central): Own and maintain enterprise systems
• Engineering / Automation: Support equipment and operational technologies
  
  

Core Competencies

• Knowledge of manufacturing and supply chain enterprise systems
• Strong shop floor process expertise (batch and/or discrete manufacturing)
• Hands-on, problem-solving mindset
• Effective communication and training skills
• Ability to bridge Operations, IT, and Engineering teams
• Influencing skills with the ability to drive cross-functional alignment
• Structured, detail-oriented, and compliance-focused
  
  

Required Qualifications

• Bachelor’s degree in Engineering, Information Technology, Life Sciences, or a related field
• 7–10 years of hands-on experience supporting manufacturing applications in a production environment
• Strong knowledge of GMP regulations, including 21 CFR Part 11 and Computer System Validation (CSV)
• Demonstrated experience in pharmaceutical manufacturing and/or packaging environments preferred
• Experience working with MES and/or ERP systems as an end user
• Understanding of operational technology, including PLCs, SCADA, and equipment interfaces
  
  

Key Success Factors

• Ability to operate both strategically and hands-on in a fast-paced manufacturing environment
• Strong engagement with shop floor teams to understand real-time execution challenges
• High user adoption and correct system utilization
• Effective collaboration across business process, IT, and engineering teams
• Commitment to compliance, quality, and data integrity