Key User - Shop Floor Operations - Pl2P

Datwyler•Middletown, NJ

10h

About The Position

The Digital Manufacturing 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.

Requirements

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)

Nice To Haves

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

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