Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries ?PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas .Due to a constant growth, we are looking for aComputer System Validation Specialistto join our team inBarcelona, Spain.This is a hybrid role ( 2 days working from home ) and requiresstrong Spanish language skillsat a professional level.Responsibilitiesinclude, but are not limited, to the following:Contribute to the execution of CSV projects, ensuring alignment with GxP requirements, 21 CFR Part 11, EU Annex 11, and applicable guidelines.Preparation of validation documentation:Assist in drafting and reviewing technical documents such as validation plans, protocols (IQ/OQ/PQ), reports, and risk assessments.Execution of testing activities:Participate in protocol execution, test result documentation, and deviation management as needed.Collaborate in collecting information, performing preliminary risk analyses, and defining mitigation actions.Cross-functional collaboration:Work closely with IT, Quality Assurance,



and other business functions to ensure proper implementation of compliance requirements.Regulatory awareness:Stay informed about relevant regulations and industry best practices related to computer system validation.Client support:Provide operational and consulting support to clients during CSV activities.RequirementsBachelor’s or Master’s degree inScientific or Technical disciplines(Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).+3 yearsof experience in thePharmaceutical industryor in a related validation/qualification role.Basic to intermediate understanding ofGxP regulations ,21 CFR Part 11 ,EU Annex 11, and other compliance requirements.Native-level Spanish (mandatory)and good command ofEnglish(B1-B2).Familiarity withGxP-regulated computer systems, test management tools, and CSV-related tools.Strong skills intechnical documentationpreparation and updating.Goodorganizational skills, teamwork attitude, problem-solving mindset, and motivation to grow in theCSV consultingfield.Next StepsUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.If there's a positive match, a technical interview with the Hiring Manager will be arranged.In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs a member of the PQE team, you will be part of achallenging, multicultural company that values collaboration and innovation. PQE Group gives you theopportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.If you are looking for arewarding and exciting career, PQE Group is the perfect place for you.#J-18808-Ljbffr

📌 Computer System Validation Specialist (Madrid)
🏢 Pqe Group
📍 Madrid