Pharma IT Systems Specialist - Validation & MES Expert

FITS, LLC

Manatí (PR)

On-site

USD 70,000 - 100,000

Full time

6 days ago

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Benefits offered by this job

Excellent customer service

Job summary

FITS, LLC is seeking an IT validation specialist for Validation services in Manufacturing Operations and Business Process areas. The role requires a BS in CS/CE/EE/IT and 5 years of IT experience in pharmaceutical manufacturing, with 3 years in process automation and 2 in computerized systems validation.

The position offers 1st shift with potential for 2nd/3rd and weekend shifts, flexible hours, and a bilingual English/Spanish requirement.

Qualifications

Bachelor's degree in CS/CE/EE/IT with 5 years IT experience in pharma manufacturing.
3+ years in process automation and 2+ years in computerized systems validation.
Bilingual: English and Spanish (verbal/written).
Experience with validation docs per GAMP 5 and 21 CFR Part 11.

Responsibilities

Provide IT expertise to process equipment and automation systems for manufacturing operations.
Enhance, develop and support MES applications including validation execution.
Perform process analysis and validate improvements for automation systems.
Join implementation projects for integrated business applications and automation.
Support installation, configuration, troubleshooting and maintenance of computerized systems.
Train users to ensure proper use of software following procedures.
Assist Site Automation/Manufacturing in workload/capacity planning.
Review and test programs to meet hardware/software requirements.
Assess component loss criticality and draft recovery recommendations.
Provide project status updates and strive to meet milestones.