CSV Engineer (Pharma)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
CSV Engineer (Pharma): Supporting validation and qualification activities within a pharmaceutical environment with an accent on regulatory compliance and GxP standards. Focus on preparing validation documentation, ensuring system compliance, and collaborating with cross-functional teams for system integration.
Location: Hybrid • Boxmeer (Netherlands)
Company
IT consultancy firm that helps startups, mid-sized and large corporations to create and deliver innovative technologies across various industries.
What you will do
- Prepare, review, and approve validation documentation for computerized systems.
- Maintain accurate and compliant validation records.
- Support validation and qualification activities to ensure compliance with regulatory standards.
- Ensure systems are used in line with GxP regulations and internal protocols.
- Train end users on proper system usage and compliance requirements.
- Collaborate with cross-functional teams to support system integration and improvements.
Requirements
- Bachelor's degree in IT, Business, or a related field.
- Experience working in a GxP-regulated environment.
- Understanding of computerized system validation (CSV) processes.
- Excellent written communication skills in English.
- Ability to work independently with moderate supervision.
Nice to have
- Knowledge of automation systems (ISA-95 level 2/3).
- Experience with SDLC (Systems Development Lifecycle).
- Exposure to manufacturing systems or pharma environments.
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