Specialist, Manufacturing Execution System (MES)
The Manufacturing Execution System (MES) Specialist acts as a subject matter expert for authoring and updating electronic master batch records. The primary responsibility is to ensure that the deployment of the Werum/Korber PAS-X electronic Master Batch Records are successfully and supported to maximize business benefits and are in line with site business process and technical standards. The MES Specialist will also be responsible for MES integrations – DCS, SAP, LIMS etc.
The specialist will be supporting MES trainings, collaboration, benefit realization, and standardization. The Specialist will follow the standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes. The MES Specialist is responsible for activities that include the following:
· Identifies and implements continuous process improvement opportunities.
· Sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Werum/Korber generic configuration.
· Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance.
· Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations. Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit.
Required Experience and Skills:
• Direct experience with MES (PAS-X) with nice to have experience in MBR, GMBR.
• Proven track record of analytical skills, problem solving and attention to detail.
• High personal integrity, credibility, and energy
• Excellent communication and influencing skills while working.
• Strong written and verbal communication skills.
• Strong understanding of manufacturing principles/processes and ability to translate
manufacturing requirements into Automation/Digital Solution.
· Knowledge of SAP, MuleSoft interface.
· Knowledge of L2 Systems (Historian, SCADA, DCS) integration with PAS-X MES
Responsibility:
• Provide first and second-line support for MES – PAS-X applications.
• Troubleshoot and resolve application issues reported by users. Resolving Incident/ problems • within SLA (response time/ resolution time)
• Monitor application performance and ensure efficient functionality.
• Communicate with users to understand and resolve issues promptly. Verbal and written communication with end users/ IT stake holders in process of finding resolution
• Document all support activities and solutions in the ticketing system.
• Escalate complex issues to third-line support or development teams.
• Collaborate with the development team to identify and resolve bugs. Estimating and implementing changes (proactive/ reactive) to permanently fix the incident or as a planned change
• Conduct routine checks and maintenance of the PAS-X applications.
• Ensure compliance with all regulations and standards.
• System validation as per Quality process and SoPs
• System/ application administration activity (periodic maintenance, process compliance e.g. GMP audit, security administration, capacity planning etc.)
· Available to work in rotational shifts including night, morning and weekend shift.
· Availability to work outside office hours when the need arises.
· Ability to prioritise the criticality of support issues as they arise and act accordingly.
· Able to pick up Cross-Trainings and willing to learn other OT applications.
· Write, review and update KBA Documents for the Support Team.
· Perform periodic monitoring and qualification testing on new / existing systems according site procedures.