Senior IT Operations Support Specialist
JOB DESCRIPTION: Accountable for providing operational IT support on computerized systems in the Manufacturing, Laboratories/QA, Facilities and Utilities areas including the monitoring and management execution of operational site mission critical systems like: Syncade, Delta V, Laboratories Information Management System, Empower-Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and stand alone computers . Also accountable for leading the validation team in the design, development and execution of validation plans and protocols for the systems in scope.
• BS in Science, Computer/Information Technology or Engineering
• Six (6) years of experience in pharmaceutical / manufacturing operations or software development environment
• Five (5) years of combined experience in process automation or laboratory systems, information systems, and computerized systems validation.
• Proven project management skills
• In-depth knowledge of the science and computerized systems involved in the design, installation, commissioning and validation/qualification of computerized systems as applied to pharmaceutical production environment
• Proficient knowledge of computer system development life cycle concepts, change control systems and FDA and EMEA regulatory requirements, including 21 CFR Part 11
• Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications
• Experience with external and internal regulatory audits
• Knowledge of mechanical concepts, electrical controls theory and electronic circuitry
• Broad experience in the design, development and implementation of infrastructure, MES and Quality Systems
• General knowledge in applications such as: Maximo CMMS, TrackWise QMS, DCA DMS, Data Historian and laboratory systems
• Ability to manage and operate computer software packages used for data acquisition systems and PLC programming
• Skilled with Microsoft operating systems and MS Office applications
• Knowledge of Computerized Equipment/Operating Systems: Client Server environment, Windows, Relational Databases: Oracle, SQL, etc.
• Knowledge of SAP/R3 highly desirable
• Excellent communication skills (oral, written and reading) in Spanish and English
• Available to work in the 2nd, 3rd or weekend shifts and willing to work flexible hours, changing shifts (rotational work shifts), nights and weekends as required per business needs based on business needs .
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