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- IT portfolio and program management for new company division production buildings (opened 4 production plants)- Responsible of plant-wide teleconference meeting offices technology & resources- New product introduction (NPI) management & requirements / BCP & DRP- Major incident management for Guadalajara (Green Point division)- Service delivery process / operation’s training plans- OKTA/Workday/Kronos/Service Now integration projects- Implemented purchase order processes with clients through SAP (B2B, ERP integrations)- Implemented secure network transmission processes (AS3, SFTP) - Creation of business case’s and capital investment requirements- Customer/Business relationship management- Implementation of file transfer protocols management systems (sFTP, AS3, Modbus, TCP/IP, SSH)- Responsible for managing contractors and service providers for IT services- Budget management- Management of software development life cycle (SDLC) with scrum & waterfall frameworks- Manage resource capacity (internal & external collaborators)- CAPEX/OPEX planning- Telecomm & Server infrastructure implementations / hot & cold on-premises & cloud storage (AWS)- Structured cabling implementations- Standard Operating Procedure management- IT Audit planning & execution- Project documentation within PMI framework

IT Director @ Kona Consulting Group

Lead my team towards achieving our corporate goals and principles. Our activities include:• Computer System Validation, Site Assurance & System Assessments• Support Local IT Projects & BAU IT QM activities• Ensure awareness to the site IT team on Regulations and Compliance needs• Ensure adherence to IT Processes & Training Compliance• Support Agency Inspections• Perform IT Supplier Assessments & Reassessments• Enforce Sarbanes-Oxley compliance and awareness• Enforce GxP knowledge, training & continuous awareness

• Computer System Validation under System Development LifeCycle methodology (SDLC) and ISPE GAMP5 guide• Records Information Management (RIM) in compliance with SOX act• Production equipment upgrades and solutions under Merck Production System methodology• Commissioning and Qualification of GMP systems and equipment’s• Project Management• Process Validation documentation• Periodic Reviews strategies• Risk analysis (AMEF)Achievements (authorized capital projects):• USD $4.2M for plant upgrade (4 year project)• USD $200k for plant-wide efficiency measurement system (1 year project)Technical Skills:• Languages: C++, Visual Basic, Java, Assembly, AWL, KOP• Operating Systems: Windows Server 2003, Windows Server 2008, Windows XP, Windows 7• Databases: Microsoft SQL• Networking: HTTP, TCP/IP, FTP• Computational packages: SAP, TrackWise, LIMS, MS Sharepoint, MS Office, RSLogix 500 & 5K, TrakSYS, Apogee Insight, Osisoft PI, Freeweigh.NET, IBM MAXIMO, REMEDY, DISY, MiniTab, STEP 7, LABVIEW

- Accountable for the Automation team (3) and project’s resourcing and business case proposals- Responsible of answering FDA audits as the senior automation team leader- Responsible of plant-wide systems and equipment’s Computer System Validation (CSV)- Responsible of training and qualification of personnel in the automation area- Responsible of equipment’s commissioning, upgrade and retirement (commissioning, FAT, SAT, IOQ, CSV, decommissioning and retirement)- Responsible for service providers before production areas (manufacturing, acquired materials, warehouse’s, facilities, quality assurance)- Elaboration and execution of FAT, SAT, IQ/IV, OQ, PQ protocols- Implementation & Administration of BMS/BAS platforms (DeltaV, Apogee Insight, Osisoft PI Historian, WinDSX security access, IBM Maximo, SCADA, FactoryTalk)- Enforcement of GAMP5’s correct application- Continuous improvement projects using tools such as Kaizen, 5s, Six Sigma, Lean tools- Process validation documentation and strategies- Responsible of plant-wide periodic review annual strategy- Retirement strategies (plant-wide and per equipment)- Risk analysis and assessment in every manufacturing plant’s project (ISPE guidelines)- Production operational support (parenteral, dry products, liquids, cephalosporin, packaging, laboratories, facilities, utilities, critical systems, software platforms, acquired materials, warehouse’s, supply chain)- Responsible for the preventive and corrective maintenance of computer-based equipment’s of plant facilities (HVACs, compressed air, pure- steam generators, wastewater treatment plant, boiler room)Computational packages: MS Office, RSLogix 500 & 5K, TrakSYS, Apogee Insight, Osisoft PI, Freeweigh.NET, IBM MAXIMO, REMEDY, DISY, TrackWise, MiniTab, STEP 7, LABVIEW, AdminLIMS, GlobalLIMS

ITC servicesITC AuditsServer administrationUser support

IT servicesOperating SystemsNetwork troubleshooting