Técnico en Validación de Equipos de Laboratorio (CSV)

Kymos Group; Barcelona; Híbrido; EUR 50.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

Flexible working hours

23 vacation days + holidays

Office rooftop & canteen access

Descripción de la vacante

KYMOS GROUP in Spain seeks a Computer System Validation professional to ensure compliance of analytical systems. You will draft validation artifacts, manage test plans and collaborate with QA and IT on change controls.

You will support audits and maintain software for instrument management, working closely with Laboratory staff and quality teams in a hybrid office setting.

Formación

• Degree in Engineering, Chemistry or Physics, or similar.
• Proven experience in computer system validation.
• Regulatory guidelines: GAMP 5, EU Annex 11, and GxP.
• Ability to draft validation documentation and test plans.

Responsabilidades

• Collaborate on computer system validation tasks and data integrity compliance.
• Draft validation documentation per instrument life cycle and GXP/GAMP 5.
• Develop and maintain test plans, scripts and UAT tests.
• Manage changes with QA and IT, assess impact and validation requirements.
• Perform periodic reviews and maintain instrument support software.
• Assist QA during audits and regulatory inspections.

Conocimientos

Self-motivated

Organisational skills

Time management

Ability to work with minimal oversight

Regulatory knowledge

GAMP 5 familiarity

EU Annex 11 knowledge

GxP compliance

Teamwork with Lab IT QA

Pressure tolerance

Query resolution with lab users

Spanish and English (C1) proficiency

Educación

Engineering degree

Herramientas

LIMS (LabWare)

Empower

MassHunter/Chromeleon

Descripción del empleo

KYMOS 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.

KYMOS 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.

KYMOS 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.

Kymos 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).

The 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.

Your responsibilities will be:

Collaborate 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.

Draft 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.

Support the development and maintenance of test plans, test scripts and user acceptance tests and manage the execution of test plans.

Manage 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.

Carry out periodic reviews of the computerized system and maintain and verify the different support software for the management of the instruments.

Assist Quality Assurance during client audits and regulatory inspections in computer system validation issues.

Education:

You should have a degree in Engineering, Chemistry or Physics, or similar, with proven experience in computer system validation.

Required skills for the position:

• Self-motivated with good organisational / time management skills and ability to work with minimal supervision.
• Regulatory knowledge and compliance guidelines: GAMP 5, EU Annex 11, and GxP.
• Teamwork skills for an effective work in collaboration with Laboratory staff and IT, LIMS and Quality Assurance Departments.
• Ability to work under pressure to tight deadlines.
• Ability to identify and address a query from laboratory users.
• Continuous development of system / software knowledge.
• Advanced level of Spanish and English (C1), both spoken and written.

If you join us, you will enjoy:

• Working in a dynamic company with a highly qualified growing team
• Professional development and collaborative environment and a culture of empowerment.
• Flexible Working Hours and intensive schedule on Friday.
• Hybrid work, but mainly in the office.
• Access to the employee benefits flexibility platform.
• 23 vacation days per year plus 24th and 31th of December.
• Fully stocked canteen and rooftop space (coffee, fruits, snacks, and beverages).
• Our headquarters located in Cerdanyola del Vallés, an amazing place at the foothill of Collserola Park, the green lung of Barcelona, with our Rooftop terrace.

Kymos 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