CSV Validation Specialist
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
15-10-2025
Vacancies:
1 Vacancy
Job Summary
We are seeking a highly skilled and detail-oriented CSV Validation Specialist to lead validation activities for computerized systems related to labeling inspection and vision technologies in a regulated pharmaceutical environment. This role ensures that all systems meet compliance requirements and operate reliably throughout their lifecycle supporting product integrity and regulatory readiness.
Key Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for computerized systems used in labeling inspection and vision technologies.
- Author and maintain validation documentation including URS risk assessments traceability matrices and validation summary reports.
- Ensure compliance with FDA 21 CFR Part 11 EU Annex 11 GAMP 5 and internal CSV policies.
- Lead periodic reviews audit trail assessments and user access evaluations for validated systems.
- Support investigations and change controls related to labeling and inspection equipment.
- Coordinate with OEMs and vendors for technical support system integration and qualification activities.
- Participate in project planning including timelines resource coordination and documentation deliverables.
Requirements
- Bachelors degree in Engineering Computer Science Life Sciences or related field.
- Minimum 3 years of experience in CSV within the pharmaceutical or regulated industry.
- Hands-on experience with labeling systems automated inspection equipment and vision technologies.
- Familiarity with serialization systems and packaging line integration.
- Bilingual (English and Spanish)
- Proficiency in technical writing and documentation tools.
Company Industry
IT Services and IT Consulting
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
