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Job Summary
We are seeking a highly skilled CSV Validation Specialist to join our team at Bacthera Spain, SL. As a CSV Validation Specialist, you will play a critical role in ensuring the quality and integrity of our computer systems.
Key Responsibilities
- Develop and execute Computer System Validations for 4 facilities, ensuring compliance with global and local company policies, legal requirements, and health authority regulations.
- Plan, develop, and execute CSV policies, SOPs, and risk assessments aligned with applicable regulatory expectations and industry standards.
- Lead assigned CSV projects and provide guidance to local teams, ensuring timely and accurate completion.
- Coordinate and communicate with stakeholders to ensure accurate and timely completion of CSV tasks.
- Review and analyze related deviations, CAPAs, and changes, and perform yearly system reviews for each system.
Requirements
- Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or a related field.
- A minimum of 5 years of experience in CSV, MES, SCADA, and OT systems.
- Good understanding of manufacturing processes and related process equipment.
- Extensive experience in a regulated pharmaceutical environment and GMP requirements.
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- Structured, focused, and well-organized working attitude.
- Independent way of working and taking ownership of assigned tasks.
- Working knowledge of quality systems and regulatory requirements across multiple health authorities.
- Proficient in Spanish and English.
- Ability to travel occasionally to different sites.
What We Offer
- Atractive salary.
- Languages courses offered.
- Flexible working hours.
- International and highly motivated team.
