Senior CSV Expert

Job title:

Senior CSV Expert

Company:

Bacthera Spain, SL

Job description

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 QualityTareasDeveloping CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standardsDeveloping of protocols for CSV in accordance with policy and proceduresLeading assigned CSV for the process equipment of 4 facilities and providing guidance to local teamsLeads and supports CSV projects and related activities for IT supported systemDelivery of a complete validation packageUser Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and ExecutionTraceability Matrix, Validation Summary Report, Configurations SpecificationCoordinating the cooperation between other system stakeholders (e.g. IT, Suppliers, etc.) including the alignment of Service Level neededCoordinating/Handling the CSV tasksFollow up changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and ITPerforming the yearly system review for each systemReviewing and analyzing related Deviations, CAPAs and Changes

Coordinating and communicating with stakeholders to ensure accurate and timely completionRequisitos

• 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)

BeneficiosStart-up and innotative company within a fast decission environmentFlexible working hours (on site)International and highly motivated teamAtractive salaryLanguages courses offeredBacthera Spain, SL

Expected salary

Location

Schweiz – Danmark

Job date

Wed, 01 May 2024 22:08:54 GMT

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