Production Systems Expert

Job Description Summary
The Production Systems Expert is responsible for managing, maintaining, and continuously improving digital manufacturing systems that support production and packaging operations in a GMP-regulated environment.
This role serves as a key interface between Manufacturing, Quality, Engineering, Automation, and IT/OT functions to ensure compliant, reliable, and efficient operation of manufacturing digital systems.
The position is primarily focused on Manufacturing Execution Systems (MES), Electronic Batch Records (EBR/MBR), S4HANA manufacturing processes, Serialization and Track & Trace solutions, Historian platforms, and other manufacturing systems that enable digital manufacturing operations and site digital transformation.
The role is responsible for ensuring that manufacturing systems are implemented, maintained, and continuously optimized in alignment with GMP requirements, operational needs, and business objectives. The successful candidate will work closely with business stakeholders and cross-functional teams to identify system improvement opportunities, support digitalization initiatives, and deliver sustainable manufacturing solutions.
Design, create, maintain, and continuously improve Electronic Batch Records (MBRs) and related digital manufacturing solutions in accordance with operational, quality, and compliance requirements.
Please note that this role is primarily focused on Manufacturing Execution Systems (MES), Electronic Batch Records (EBR/MBR), and manufacturing digitalization. Candidates with hands-on experience in manufacturing systems will be strongly preferred over traditional production operations profiles.
Job Description
Major AccountabilitiesMES & Digital Manufacturing
Coordinate end-to-end MES implementation activities, including new product introductions, system releases, upgrades, and digital transformation initiatives.
Design, create, maintain, and continuously improve Electronic Batch Records (EBRs/MBRs).
Act as the subject matter expert for Manufacturing Execution Systems (MES) and related digital manufacturing platforms.
Ensure MES solutions are aligned with GMP requirements, operational needs, and business objectives.
Support implementation of electronic batch recording and associated digital manufacturing capabilities across production and packaging operations.
Manufacturing Systems Ownership
Coordinate, maintain, and continuously improve manufacturing systems including: MES (Manufacturing Execution System)S4HANA Manufacturing ProcessesMACOSeidenader Track & TraceAGE Aggregation SystemHistorian
Ensure reliable operation, compliance, data integrity, and inspection readiness of all manufacturing systems.
Provide technical support and troubleshooting for manufacturing systems while minimizing impact on production operations.
Monitor system performance and identify opportunities for optimization and continuous improvement.
Digital Transformation & Projects
Support site digital transformation initiatives and contribute to the successful execution of the site's digital roadmap.
Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to identify automation, digitalization, and system optimization opportunities.
Lead or contribute to requirements gathering, solution design, testing, deployment, user training, go-live, and hypercare activities.
Support implementation of new manufacturing technologies, digital solutions, and system enhancements.
Drive process simplification and digital innovation initiatives that improve operational efficiency and compliance.
Compliance & Continuous Improvement
Ensure inspection readiness by maintaining up-to-date manufacturing systems procedures, documentation, and compliance records.
Support internal audits, external inspections, and GMP compliance activities.
Investigate recurring or critical system issues, support root cause analysis, and drive sustainable CAPAs.
Assess the operational and compliance impact of system changes and ensure appropriate controls are in place.
Promote knowledge sharing and cross-training within the Manufacturing Systems team.
Minimum RequirementsEducation
Bachelor's or Master's degree in Chemical Engineering, Chemistry, or Pharmacy.
ExperienceRequired
Minimum 3 years of experience in Manufacturing Systems, MES, Digital Manufacturing, Production Technology, Automation, or related functions within a GMP/GxP-regulated environment.
Hands-on experience with Manufacturing Execution Systems (MES).
Experience working with Electronic Batch Records (EBR/MBR) and digital manufacturing processes.
Experience supporting manufacturing system implementations, upgrades, or digitalization projects.
Experience collaborating with Manufacturing, Quality, and IT/OT organizations.
Fluent in written and spoken English.
Preferred
Experience with S4HANA manufacturing processes and integration with manufacturing systems.
Experience with Serialization, Aggregation, and Track & Trace systems.
Experience with Historian platforms and manufacturing data management solutions.
Experience participating in manufacturing digitalization and Industry 4.0 initiatives.
Knowledge of computerized systems compliance and data integrity requirements within GMP-regulated environments.
Skills
Strong understanding of manufacturing processes and digital manufacturing systems.
Strong analytical thinking and problem-solving capabilities.
Ability to understand system interfaces and evaluate operational and compliance impacts.
Strong stakeholder management and communication skills.
Project management and execution mindset.
Continuous improvement and operational excellence mindset.
Strong digital and technology affinity with the ability to quickly learn new systems and platforms.
Team-oriented and customer-focused approach.
Ideal Candidate Profile
We are looking for candidates with practical experience in manufacturing systems and digital manufacturing solutions rather than traditional production supervision roles.
The ideal candidate has hands-on experience with MES, EBR/MBR management, S4HANA manufacturing processes, Serialization and Track & Trace systems, Historian platforms, and manufacturing digitalization projects. They are comfortable working across Manufacturing, Quality, Engineering, and IT/OT functions and are passionate about enabling digital transformation within a GMP-regulated manufacturing environment.
Skills Desired
Data Analytics