Juan Alicea

Lilly del Caribe

• Generation of engineering specifications and drawings, review of engineering documents, field-testing of equipment/systems
• Control system design, control panel engineering, SCADA, PLC and HMI programming and testing, control system start-up, troubleshooting, maintenance and support.
• Design/verify field installations, test and provide information management solutions to meet customer requirements.
• Responsible for industrial automation/control system integration and related support systems such as Data Historian, EBR's, Alarm Management and PI.
• Experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5
• Field Support to constructions projects. Panel constructions, wiring panels and wiring instruments used for drug manufacturing areas.
• Create and execute validation Tests on ALM (Application Lifecycle Management).
• Develop and execute Computerized System Validation (CSV) deliverables for control systems.
• Develop and execute gap assessments and remediation activities for the Data Integrity initiatives for all production industrial control systems

Amgen

• Develop and execute gap assessments and remediation activities for the Data Integrity initiatives for all production industrial control systems.
• Field Support to AML1 Data Integrity Remediation's Project.
• Create and execute work orders on MAXIMO program.
• Navigate through SYSTECH and other equipment to provide field information to execute security assessments.

• Support EBR configurations for the AML 1 inspection and packaging lines, Troubleshooting and system design codification using WERUM- PASX platform
• Requirements - Gather user requirements in relation to controlling and recording manufacturing activities
• EBR Design - Design of the electronic batch record, forms, process workflows and process interdependence with data stored in OSI PI Historian
• Create parameters values list and attach it to the PMBR to be able to create orders to the manufacturing process
• EBR Configuration - Configure the EBRs for all the manufacturing areas using WERUM-PASX platform to launch of designated products and maintenance of existing processes
• EBR Testing - Perform Simulation and live testing of the EBRs to debug batch record execution, identify any potential gaps in terms of process or communication and prepare the system for validation once it is in approved stage
• Equipment Management Configuration - Configure the Equipment Management tool, including electronic equipment use records, reports, state diagrams design and challenge
• Equipment Management Testing - Simulation and live testing of the Equipment Management tool to debug system integration with EBR and standalone functionality
• Validation Support - Support the integrated MES validation through execution of the integration system.

• Primary responsibility is to perform system Integration with OSI Pi Data Historian and OPC Servers/Clients to the MES (PAS|X) platform at Amgen Manufacturing Limited Support EBR configurations for the Repatha AML 6 Project, Troubleshooting and system design codification using WERUM- PASX platform
• Prepare documentation needed for the validation process: MEMO (document where all changes were documented with the proof of a validated run with the changes) Protocol Test Scripts Requirements - Gather user requirements in relation to controlling and recording manufacturing activities
• EBR Design - Design of the electronic batch record, forms, process workflows and process interdependence with data stored in OSI PI Historian
• EBR Configuration - Configure the EBRs for all the manufacturing areas using WERUM- PASX platform to launch of designated products and maintenance of existing processes.

• EBR Configuration - Configure the EBRs for all the manufacturing areas using WERUM- PASX platform to launch of designated products and maintenance of existing processes
• Master Batch Record (MBR) Validation trough Application Lifecycle Management Prepare documentation needed for the validation process: MEMO (document where all changes were documented with the proof of a validated run with the changes) Protocol Test Scripts Manufacturing Execution System (MES) Implementation Primary responsibility is to perform system Integration with OSI Pi Data Historian and OPC Servers/Clients to the MES (PAS|X) platform at Amgen Manufacturing Limited
• Support EBR configurations for the Repatha AML 6 Project, Troubleshooting and system design codification using WERUM- PASX platform
• Requirements - Gather user requirements in relation to controlling and recording manufacturing activities
• EBR Design - Design of the electronic batch record, forms, process workflows and process interdependence with data stored in OSI PI Historian
• EBR Configuration - Configure the EBRs for all the manufacturing areas using WERUM- PASX platform to launch of designated products and maintenance of existing processes
• EBR Testing - Perform Simulation and live testing of the EBRs to debug batch record execution, identify any potential gaps in terms of process or communication with SAP, PI Historian etc
• And prepare the system for validation once it is in approved stage
• Equipment Management Configuration - Configure the Equipment Management tool, including: Electronic Equipment Use Records, reports, state diagrams design and challenge
• Equipment Management Testing - Simulation and live testing of the Equipment Management tool to debug system integration with EBR and standalone functionality
• Validation Support - Support the integrated MES validation through execution of the integrated system.

• Create Test Scripts for the validation process
• Primary responsibility is to perform system Integration with SCADA to the MES (PAS|X) platform at Amgen Manufacturing Limited
• Support EBR configurations for the Line 4137 Project, Troubleshooting and system design codification using WERUM- PASX platform
• Requirements - Gather user requirements in relation to controlling and recording manufacturing activities EBR Design - Design of the electronic batch record, forms, process workflows and process interdependence with data stored in OSI PI Historian
• EBR Configuration - Configure the EBRs for all the manufacturing areas using WERUM- PASX platform to launch of designated products and maintenance of existing processes
• EBR Testing - Perform Simulation and live testing of the EBRs to debug batch record execution, identify any potential gaps in terms of process or communication with SAP, SCADA etc
• And prepare the system for validation once it is in approved stage

• Responsible for design a route for the underground and aerial fiber optic installations
• Meeting with contractors to give possible projects
• Participate in site survey to analyze the design and possible cost of the projects
• Troubleshooting regarding fiber cable maintenance and repair activities
• Field Supervision