The Manufacturing Execution System (MES) Specialist/MBR Author 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 compliantly designed, developed, deployed, 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 updating the Master batch records 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 master batch record (GMBR) 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.

·          Work directly with Manufacturing sites point of contacts to understand the requirements related to MBR/GMBRs and implements them following the SOPs and Life cycle procedures using electronic validation softwares like eVal (Kneat Validation Software).

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Education Minimum Requirement:

• Bachelor’s Degree and 5+ years of MES support experience or 7+ years of relevant MES experience

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Required Experience and Skills:

• Direct experience with MES (PAS-X) with strong experience in MBR, GMBR design.

• 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 with Global stakeholders (North America, Europe & Singapore).

• Strong written and verbal communication skills Minimum five (5) years of experience in a production regulated industry.

• Strong understanding of manufacturing principles/processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solution

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Preferred Experience and Skills:

• Knowledge of SAP

· Knowledge of L2 Systems (Historian, SCADA, DCS) integration with PAS-X M

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