| Location | Zuid-Holland, Netherlands |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 26471 |
| Published | 13 minutes ago |
Job Description
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.
Education: Bachelor’s or Master’s degree in Engineering, Information Technology, Pharmacy, or a related scientific field.
Experience: 3-4 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.
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.
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 o.titelman@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.