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Senior CSV Expert

hace 2 meses

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

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. Our global presence spans across multiple locations, and we bring together best-in-class complementary capabilities.

Job Summary

We are seeking a highly skilled Senior CSV Expert to join our team. As a Senior CSV Expert, you will be responsible for 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
  1. Develop and Implement CSV Policies and Procedures: Develop and implement Computer System Validation policies and procedures aligned with applicable regulatory expectations and industry standards.
  2. Lead CSV Projects: Lead assigned CSV projects for the process equipment of 4 facilities and provide guidance to local teams.
  3. Develop and Execute Validation Protocols: Develop protocols for CSV in accordance with policy and procedures, and execute validation protocols for IT-supported systems.
  4. Deliver Validation Packages: Deliver complete validation packages including User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and Execution, Traceability Matrix, Validation Summary Report, and Configurations Specification.
  5. Coordinate with Stakeholders: Coordinate the cooperation between other system stakeholders (e.g., IT, Suppliers, etc.) including the alignment of Service Level needed.
  6. Manage CSV Tasks: Manage and coordinate CSV tasks, including following up on changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT.
  7. Perform System Reviews: Perform the yearly system review for each system.
  8. Review and Analyze Deviations: Review and analyze related Deviations, CAPAs, and Changes.
  9. Communicate with Stakeholders: Communicate and coordinate with stakeholders to ensure accurate and timely completion.
Requirements
  1. Education: Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or related field.
  2. Experience: A minimum of 5 years of experience in CSV, MES, SCADA, and OT systems.
  3. Manufacturing Knowledge: Good understanding of manufacturing processes and related process equipment.
  4. Regulatory Knowledge: Extensive experience in a regulated pharmaceutical environment and GMP requirements.
  5. Communication Skills: Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
  6. Organizational Skills: Structured, focused, and well-organized working attitude.
  7. Independent Work: Independent way of working and taking ownership of assigned tasks.
  8. Quality Systems: Working knowledge of quality systems and regulatory requirements across multiple health authorities.
  9. Language Skills: Proficient in Spanish and English.
  10. Travel: Ability to travel occasionally to different sites.