MES Rockwell Techno-Functional Lead

仕事内容

Role: MES Rockwell Techno-Functional Lead

Start date: ASAP

Location: Puurs (Near to Brussels), Belgium

Duration: FTE or Permanent

Years of Experience:12+ Years

Key responsibilities include:

· Collaborate with business stakeholders and implementation partners to configure, build, and deploy the MES systems.

· Lead the cross-functional technical team to ensure a successful implementation of systems and technology.

· Collaborate with business process leads to design master data, recipes, etc.

· Work with business units, application developers, security, and infrastructure engineering to troubleshoot, design and build application integrations that support critical manufacturing processes across operations, quality, and materials.

Manufacturing Automation and MES Experience:

· Must have 12+ years of experience with MES, preferably Rockwell FTPS in Biotech and API Manufacturing

· Must have hands-on experience in a biotech manufacturing business processes

· Must have Pharma MES design and implementation experience

· Strong knowledge of process automation systems like PLC, DCS, SCADA and their integrations to MES as well as ERP

· Able to design control strategy as per ISA 95 from L0 to L1

· Strong knowledge of communication protocols and interfaces like OPC, TCPIP, Ethernet, Control Net, Device Net

· Strong knowledge in design and define batch recipe as per ISA 88

· Should be able to architect recipe and data requirements to fulfill Mfg. Batch Records

· Strong knowledge of implementation of MES EBR and RbE

· Strong knowledge of Biotech process and Utility Equipment operations and local control systems

· Knowledge of Pharma Manufacturing Enterprise technology like SAP, Oracle, JDE.

· Functional knowledge of Manufacturing systems like LIMS, PRS, Labeling and Asset Management Systems

· Strong knowledge of MES module configurations like PE, PM, Data Manager, Recipe/WF designer, PR etc.

· Strong knowledge of DeltaV, PCS 7 DCS

· Able to perform systems to system, node to node and e2e data mapping

· Strong knowledge of Master data management and configurations

· Strong Knowledge of ISA95 and ISA88 Design and Implementation

· Knowledge of cGMP regulations, including 21CFR part 11, and good documentation practices.

· Hands on experience of deploying ASTMe2500, GAMP5 validation approach

· Good understanding of Webservers (Apache/JBOSS).

· Knowledge of publishing Applications, User access, Printers and Peripheral management in Citrix environment.

· Knowledge of manufacturing systems, Industry 4.0 and IIoT

· Experience working in a high speed, open and global manufacturing environment

· Strong Knowledge of Relations databases like Oracle and SQL Server, Networking, OPC Servers, Historians (OSI PI Historian) etc

· Ability to design and drive digital maturity model for shop floor systems and data enabling I4.0 capability

Ability to define digital manufacturing strategy and innovation in analytical use cases pertaining to Pharma 4.0 like MVA, CPV, OEE, PCT, RTDA, MI workbench etc.