CSV Specialist

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.
• Required Hands‑on Skills: Experience in developing and executing validation test plans, test scripts, and test cases, alongside the ability to conduct gap analyses.
• Required Scientific/Technical Knowledge: In‑depth knowledge of GAMP 5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.

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

GAMP 5 knowledge

21 CFR Part 11 knowledge

Data integrity

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

🧬Supporting Technical Operations Leaders to Build High‑Performing Biopharma Teams | Recruitment Consultant @ Panda

Join our Engineering department within a leading pharmaceutical manufacturing environment as a CSV Specialist. You will sit within the Industrial Automation team, focusing on the optimization and maintenance of computerized systems management and validation procedures. Your primary goal is to ensure the seamless execution and continuous improvement of CSV processes in accordance with global GMP standards.

In this role, you will act as a subject matter expert, leading or consulting on CSV activities for IT/OT automation projects and technical changes. You will be responsible for defining validation strategies, managing risk throughout the system lifecycle, and ensuring that all digital infrastructure remains compliant with ISPE GAMP 5, 21 CFR Part 11, and Eudralex Volume 4 Annex 11.

Job Description

• Education: Bachelor’s or Master’s degree in Engineering, Information Technology, Pharmacy, or a related scientific field.
• Experience: 3‑4 years of experience in CSV within a GMP‑regulated production environment (Pharmaceutical or Life Sciences).
• Core Technical Expertise: Strong understanding of IT/OT automation systems and QC computerized systems.
• Required Hands‑on Skills: Experience in developing and executing validation test plans, test scripts, and test cases, alongside the ability to conduct gap analyses.
• Required Scientific/Technical Knowledge: In‑depth knowledge of GAMP 5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.

Preferred Requirements

• Additional Experience: Previous experience leading or consulting on large‑scale IT/OT automation projects.
• Advanced Technical Skills: Expertise in risk management strategies and data integrity assessments.
• Specific Technologies: Familiarity with pharmaceutical manufacturing software and industrial control systems.
• Industry Exposure: Deep understanding of pharmaceutical manufacturing processes and quality systems.
• Soft Skills: Strong analytical problem‑solving abilities and the ability to mentor team members on CSV principles.

Practicalities

• Start Date: To be discussed (ASAP preferred)
• Contract Duration: Full‑time (40 hours per week)
• Location: South Holland, the Netherlands
• Additional: 40 hours per week; competitive hourly rate.

Interviews and offers can move quickly. Send your CV to Oluali Titelman at [e-mail] or call [phone] today to secure your spot in the process.

Interested in applying? Apply now to join our team.