CSV Validation Specialist (12-Month FTC)

Norgine; Hengoed; On-site; GBP 38,000 - 52,000; Full time

Job summary

Norgine is seeking a CSV Analyst for a 12-month FTC to lead validation and compliance activities across IT systems. You will work with cross-functional teams to ensure validated states are maintained and aligned with global standards.

The role focuses on risk-based validation, policy development, and incident response, with engagement in audits and continuous improvement of CSV processes.

Qualifications

• Bachelor's degree preferred.
• Experience in validation/qualification of complex computer systems.
• Thorough knowledge of cGMP regulations related to CSV.
• Good written and oral communication skills.
• Competent user of Microsoft Office.

Responsibilities

• Ensure CSV/QA processes and IT validation systems meet regulatory requirements.
• Collaborate with teams to close validation gaps identified during audits.
• Develop, review and approve CSV policies, procedures, plans and protocols.
• Support risk-based validation and creation of validation packs.
• Assist in audits and respond to audit observations and corrective actions.
• Maintain Local Validation Master Plan aligned to corporate policies.

Skills

Communication skills

Professionalism

Networking

Proactiveness

Industry knowledge

Education

Bachelor's degree preferred

Tools

ERP

LIMS

HRIS

BI

Microsoft Office

Job description

Norgine is seeking a CSV Analyst for a 12-month FTC to lead validation and compliance activities across IT systems. You will work with cross-functional teams to ensure validated states are maintained and aligned with global standards.

The role focuses on risk-based validation, policy development, and incident response, with engagement in audits and continuous improvement of CSV processes.