CSV Specialist — GMP Validation Lead for IT/OT Pharma

Panda International; Zuid-Holland; On-site; EUR 62,000 - 96,000; Full time

Benefits offered by this job

Competitive hourly rate

Job summary

A leading pharmaceutical company in the Netherlands is looking for a CSV Specialist to join their Engineering department. This role focuses on the optimization and maintenance of computerized systems management within a GMP-regulated environment. You will lead CSV activities for IT/OT automation projects, ensuring compliance with industry standards such as GAMP 5 and 21 CFR Part 11. The ideal candidate has a relevant degree, 3-4 years of experience, and expertise in risk management and validation testing.

Qualifications

• 3-4 years of experience in CSV within a GMP-regulated environment.
• Experience in developing validation test plans and conducting gap analyses.
• Strong understanding of pharmaceutical manufacturing processes.

Responsibilities

• Ensure compliance with validation procedures in computerized systems.
• Lead CSV activities for IT/OT automation projects.
• Define validation strategies and manage risk throughout the system lifecycle.

Skills

CSV expertise

IT/OT automation knowledge

Risk management

Analytical problem-solving

Education

Bachelor’s or Master’s degree in Engineering or related field

Tools

GAMP 5

21 CFR Part 11

Eudralex Volume 4 Annex 11

Job description

A leading pharmaceutical company in the Netherlands is looking for a CSV Specialist to join their Engineering department. This role focuses on the optimization and maintenance of computerized systems management within a GMP-regulated environment. You will lead CSV activities for IT/OT automation projects, ensuring compliance with industry standards such as GAMP 5 and 21 CFR Part 11. The ideal candidate has a relevant degree, 3-4 years of experience, and expertise in risk management and validation testing.