IT Systems Specialist
About The Position
For Validation services in the Manufacturing Operations and Business Process area. This role provides IT expertise support to process equipment and process automation systems for manufacturing operations, and to business process teams during process integration. The specialist will enhance, develop, and support Manufacturing Execution System (MES) applications, including user requirements, specifications, protocols, and validation execution. They will perform process analysis, recommend improvements, and participate proactively in implementation projects for new integrated business applications and automation processes. Additionally, the role involves supporting the automation group with installation, configuration, troubleshooting, and maintenance of computerized systems, providing continuous support and training to users, and evaluating system capacity for expansion or upgrades. The specialist will also review and test computer programs, determine component criticality, and provide project status updates.
Requirements
- Bachelor's Degree in Computer Science, Computer Engineering, Electrical Engineering, or Information Technology
- Five (5) years of IT experience in pharmaceutical manufacturing operations
- At least three (3) years of experience in process automation
- At least two (2) years of experience in computerized systems validation
- Experience in Computer System Validation documentation using standards like GAMP 5, 21 CFR Part 11, and related FDA/EMEA regulatory concepts.
- Experience in SYNCADE Application.
- Experience in Systems development and implementation of manufacturing and quality-related systems.
- Experience in DRP / Contingency / SLA management for optimal system up-time and minimal downtime.
- Experience in Linear and relational database (RDBMS) management, and creation of custom reports from RDBMS, preferably using Crystal Reports.
- Bilingual: English and Spanish (verbal/ written)
Responsibilities
- Provide IT expertise support to process equipment and process automation systems for manufacturing operations, and to business process teams during process integration.
- Enhance, develop and support Manufacturing Execution System (MES) applications, including user requirements, specifications, protocols and validation execution for manufacturing systems applications.
- Perform process analysis and recommend improvements, including assessment, recommendation, validation and implementation of process automation systems.
- Participate proactively as a team member on implementation projects for new integrated business applications and automation processes, providing consulting advice in the use and management of technology.
- Provide support in collaboration with the automation group for installation, configuration, troubleshooting, prototyping and maintenance of computerized systems.
- Provide continuous support and training to users to ensure proper use of software applications, following established operational procedures.
- Support Site Automation and Manufacturing teams in evaluating workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing computer operations.
- Review and test computer programs to ensure they meet manufacturer-recommended requirements for hardware and software at the personal computer and/or host computer system level.
- Determine criticality of component loss, prioritize the importance of components, and write recommendations for recovering losses using applicable backup/restore procedures.
- Provide project status updates against project plans and perform best efforts to achieve project milestones within pre-established due dates.
Benefits
- Excellent, unmatched, never-before-seen customer service of our team
- Flexible, family-oriented company culture
- Focus on employee well-being
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
