Job Description

Summary:
The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections.
Roles & responsibility:

• Knowledge on FDA Guidance's and industry Standards
• Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for computer systems.
• Assess and document system requirements, risk assessments, and user requirements specifications (URS).
• Review and approve system design, configuration, and test documentation.
• Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
• Manage change control and deviation management processes for validated systems.
• Collaborate with cross-functional teams (IT, QA, business users) to ensure validation deliverables are met.
• Maintain validation documentation and support periodic reviews and revalidation.
• Participate in internal and external audits and respond to regulatory inquiries.
• Train users and stakeholders on validated systems and compliance requirements.
• Stay current with industry trends, regulations, and best practices in computer system validation.

Education & Experience:

• Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field.
• 2+ years of experience in computer system validation or a regulated industry.
• Knowledge of applicable regulations (FDA, EMA, GxP, 21 CFR Part 11, Annex 11).
• Experience with validation methodologies (GAMP 5, risk-based validation).
• Strong documentation, analytical, and problem-solving skills.
• Excellent communication and teamwork abilities.
• Experience with ERP, LIMS, MES, or other regulated systems is a plus
• Familiarity with project management tools and methodologies
• Experience with audit preparation and participation.
• Understanding of data integrity principles.
• Certification in validation or quality assurance (e.g., ASQ, ISPE) is a plus.
• Prior work experience in Medical Device Industry, Biotechnology or Pharmaceutical industry is a plus.

Skills Required