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 we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.Senior CSV Expert (f/m/d)As a successful CSV Engineer, you ensure 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. You are responsible for planning, developing, and executing Computer System Validations for 4 Facilities. You will report to the global Head of Engineering Quality.My main tasks will be:Developing CSV Policies / SOPs and Risk Assessments aligned with applicable regulatory expectations and industry standards.Developing protocols for CSV in accordance with policy and procedures.Leading assigned CSV for the process equipment of 4 facilities and providing guidance to local teams.Leading and supporting CSV projects and related activities for IT-supported systems.Delivery of 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.Coordinating the cooperation between other system stakeholders (e.G., IT, Suppliers, etc.) including the alignment of Service Level needed.Coordinating/Handling the CSV tasks.Following up on changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT.Performing the yearly system review for each system.Reviewing and analyzing related Deviations, CAPAs, and Changes.Coordinating and communicating with stakeholders to ensure accurate and timely completion.I bring with me: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 (Denmark and Switzerland).My reasons for choosing Bacthera:#J-18808-Ljbffr
