IT Systems Specialist
On-siteManatí, Atlántico, Colombia
Job Summary
Provide IT expertise support to process equipment and process automation systems for manufacturing operations and business process teams. Enhance, develop, and support Manufacturing Execution System (MES) applications, including user requirements, specifications, protocols, and validation execution. Perform process analysis to recommend improvements, assess automation systems, and participate in implementation projects for new integrated business applications. Provide continuous support and training to users, manage DRP/SLA for system uptime, and review computer programs to ensure compliance with hardware and software requirements. Determine criticality of component loss and prioritize recovery using backup procedures. This role requires a Bachelor's degree in Computer Science or related fields with five years of IT experience in pharmaceutical manufacturing. Bilingual candidates in English and Spanish are preferred.
Required Qualifications
- 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
- Two (2) years of experience in computerized systems validation
- Shift: 1st shift (8:30 am- 5:00 pm)
- Available to work in the 2nd, 3rd or weekend shifts
- Willing to work flexible hours
- Changing shifts (rotational work shifts)
- Nights
- Weekends
- Bilingual: English and Spanish (verbal/ written)
- Experience in Computer System Validation documentation using standards like GAMP 5, 21 CFR Part 11, and related FDA/EMEA regulatory concepts
- Experience in SYNADEC Application
- Systems development and implementation of manufacturing and quality-related systems
- DRP / Contingency / SLA management for optimal system up-time and minimal downtime
- Linear and relational database (RDBMS) management
- Creation of custom reports from RDBMS, preferably using Crystal Reports
Desired Qualifications
- Commitment to serving customers with high-quality research and products
- Embracing a diverse work culture
- Commitment to the environment
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