ppKYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain (Cerdanyola del Vallés- Barcelona), Italy (Monsano-Ancona), and Germany (Frankfurt) and a Liasson office in South Korea (Seoul), offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA. /p pKYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies. /p pKYMOS GROUP has a young and dynamic staff of more than 250 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion. /p pKymos Group is made up of different laboratories with a wide variety of instruments and computerized systems, basically to provide analytical services for the pharmaceutical industry following GMP and GLP regulations and to manage the internal processes. The company has the headquarters in Barcelona and subsidiaries in Ancona (Italy) and in Frankfurt (Germany). /p pThe most significant instrumental systems are related to liquid and gas chromatography from Waters and Agilent brands, managed by the Empower software, mass spectrometry from Sciex, Agilent, and Thermo brands managed by Analyst, MassHunter and Chromeleon softwares and a myriad of other minor instrumental systems used in the physicochemical, biological and microbiological determinations carried out in the company.



The laboratory has implemented a LIMS system (LabWare) that manage the main analytical flows of the company also including the subsidiaries. /p h3Your responsibilities will be: /h3 pCollaborate on ensuring compliance with tasks linked to the computer system validation, establishing the level of compliance in data integrity and other regulatory requirements prior to system acquisition, participating in the deployment process and in post-installation qualification and validation. /p pDraft the necessary documentation for computerised systems validation in accordance with the instrument life cycle and system complexity following the current GXP regulations and GAMP 5 recommendations. /p pSupport the development and maintenance of test plans, test scripts and user acceptance tests and manage the execution of test plans. /p pManage changes in computerized systems in collaboration to Quality Assurance and IT department, evaluating the change impact and establishing the computer system validation requirements in the change control records. /p pCarry out periodic reviews of the computerized system and maintain and verify the different support software for the management of the instruments. /p pAssist Quality Assurance during client audits and regulatory inspections in computer system validation issues. /p h3Education: /h3 pYou should have a degree in Engineering, Chemistry or Physics, or similar, with proven experience in computer system validation.



/p h3Required skills for the position: /h3 ul liSelf-motivated with good organisational / time management skills and ability to work with minimal supervision. /li liRegulatory knowledge and compliance guidelines: GAMP 5, EU Annex 11, and GxP. /li liTeamwork skills for an effective work in collaboration with Laboratory staff and IT, LIMS and Quality Assurance Departments. /li liAbility to work under pressure to tight deadlines. /li liAbility to identify and address a query from laboratory users. /li liContinuous development of system / software knowledge. /li liAdvanced level of Spanish and English (C1), both spoken and written. /li /ul h3If you join us, you will enjoy: /h3 ul liWorking in a dynamic company with a highly qualified growing team /li liProfessional development and collaborative environment and a culture of empowerment. /li liFlexible Working Hours and intensive schedule on Friday. /li liHybrid work, but mainly in the office. /li liAccess to the employee benefits flexibility platform. /li li23 vacation days per year plus 24th and 31th of December. /li liFully stocked canteen and rooftop space (coffee, fruits, snacks, and beverages). /li liOur headquarters located in Cerdanyola del Vallés, an amazing place at the foothill of Collserola Park, the green lung of Barcelona, with our Rooftop terrace. /li /ul pKymos considers diversity and inclusion as key development priorities, with one of our main goals being to promote a culture that embraces differences and celebrates unique talents. For this reason, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion or any other personal characteristic /p /p #J-18808-Ljbffr

📌 Técnico en Validación de Equipos de Laboratorio (CSV) (Barcelona)
🏢 Kymos Group
📍 Barcelona