Senior CSV Expert - León, España - Bacthera Spain, SL

Descripción

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
Tareas

Developing CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standards

Developing of 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

Leads and supports CSV projects and related activities for IT supported system

Delivery of a complete validation package

User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and Execution

Traceability Matrix, Validation Summary Report, 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

Follow up 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

Requisitos

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)

Beneficios
Start-up and innotative company within a fast decission environment
Flexible working hours (on site)
International and highly motivated team
Atractive salary
Languages courses offered