Senior CSV Specialist
hace 1 mes
As a Senior CSV Expert at Bacthera Spain, you will play a crucial role in ensuring the Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health authorities.
Key Responsibilities:- Develop and execute Computer System Validations for 4 Facilities
- Plan, develop, and execute CSV policies, SOPs, and risk assessments aligned with applicable regulatory expectations and industry standards
- Lead assigned CSV for the process equipment of 4 facilities and provide guidance to local teams
- Coordinate the cooperation between other system stakeholders, including IT, Suppliers, and Service Level alignment
- Perform yearly system reviews for each system and review related Deviations, CAPAs, and Changes
- Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or related field
- 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 (Denmark and Switzerland)
- Start-up and innovative company within a fast decision environment
- Flexible working hours (on site)
- International and highly motivated team
- Attractive salary
- Language courses offered
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Senior CSV Specialist
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Valladolid, Valladolid, España Bacthera Spain, Sl A tiempo completoJob Title: Senior CSV ExpertAt Bacthera Spain, Sl, we are seeking a highly skilled Senior CSV Expert to join our team. As a Senior CSV Expert, you will play a critical role in ensuring that our Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health...
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Valladolid, Valladolid, España Bacthera Spain, Sl A tiempo completoJob Title: Senior CSV ExpertAt Bacthera Spain, Sl, we are seeking a highly skilled Senior CSV Expert to join our team. As a Senior CSV Expert, you will play a critical role in ensuring that our Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health...
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