CSV & Computer System Validation Specialist
Life Sciences
Electromechanical
Master
Advanced (5+)
- Location
- Geleen, Limburg
- Work type
- Consultancy
- Work model
- Fulltime, Hybrid
Our client, a leading organization in the life sciences sector, is seeking a professional to oversee the quality and validation of computerized laboratory systems. The role focuses on system administration and validation activities to ensure compliance with international regulatory standards in a laboratory environment.
Responsibilities
- Manage GxP laboratory system software including installation, data backups, and archival of critical data.
- Execute validation activities for new computerized systems by writing and reviewing protocols and reports.
- Identify and troubleshoot computer-related issues while coordinating deviations and change control processes.
- Audit site computerized systems and monitor the implementation of corrective and preventive action plans.
- Collaborate with laboratory end users to facilitate the efficient use of software and technical infrastructure.
- Ensure that internal regulations remain aligned with the latest regulatory requirements and industry standards.
Requirements
- Bachelor or Master degree in a scientific or technical field.
- You have 1+ years of experience in computer system validation (CSV) within a GMP or GxP environment.
- You bring knowledge of GAMP, Data Integrity, and IQ/OQ/PQ methodologies.
- You possess experience with 21 CFR Part 11 and technical software administration.
- You have excellent technical writing skills and a proactive, solution-oriented mindset.
- You are fluent in English.
Nice to Haves
- Familiarity with Cell and Gene Therapy regulations.
- Experience with software setup in OT environments.
Offer
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
Thank you for your interest. Unfortunately, job applications are not available in your region. To ensure a high-quality match for our clients and streamline the application process, we have certain regional limitations in place. We value all potential candidates and encourage you to explore opportunities with us in the future.
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