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Senior CSV Expert

hace 2 meses


Leganés, Madrid, España Bacthera A tiempo completo
About the Role

Bacthera, a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers, is seeking a highly skilled Senior CSV Expert to join our team. As a successful CSV Engineer, you will play a critical role in ensuring that 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 implement CSV policies, SOPs, and risk assessments aligned with applicable regulatory expectations and industry standards.
  • Develop protocols for CSV in accordance with policy and procedures.
  • Lead assigned CSV projects for process equipment across four facilities and provide guidance to local teams.
  • Lead and support CSV projects and related activities for IT-supported systems.
  • Deliver a complete validation package, including User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and Execution, Traceability Matrix, Validation Summary Report, and Configurations Specification.
  • Coordinate the cooperation between other system stakeholders, including IT, suppliers, and ensure alignment of Service Level requirements.
  • Coordinate and handle CSV tasks, follow up on changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT.
  • Perform yearly system reviews for each system and review and analyze related Deviations, CAPAs, and Changes.
  • Coordinate and communicate with stakeholders to ensure accurate and timely completion.
Requirements
  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or 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.
About Bacthera

Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Spain, Denmark, and Switzerland. We bring together best-in-class complementary capabilities and are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.