Position Details
About this role
This role involves managing computerized system validation activities at a biotech manufacturing site, supporting audits, deviations, and change controls to ensure compliance and system integrity.
Key Responsibilities
- Oversee CSV activities
- Support regulatory audits
- Manage deviations and CAPA
- Review validation documentation
- Ensure inspection readiness
Technical Overview
The position requires expertise in CSV, regulatory audits, validation lifecycle management, and quality systems within a biotech or pharmaceutical environment.
Ideal Candidate
The ideal candidate is a senior IT validation specialist with extensive experience in computerized system validation, regulatory audits, and quality systems within a pharmaceutical or biotech environment. They are detail-oriented and skilled in managing validation lifecycle activities.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in CSV or IT validation, No familiarity with regulatory audits, No experience with pharmaceutical quality systems
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