Técnico Validación de Sistemas Informatizados | Pharma & Laboratory Systems

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), Germany (Frankfurt), Denmark (Copenhagen) and a Liaison 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 330 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.

At
Kymos Group
, we provide specialized analytical services to the pharmaceutical industry in regulated
GMP and GLP
environments. Our laboratories are equipped with a wide range of analytical instruments and computerized systems, including solutions such as
LIMS, Empower, laboratory software, and other corporate systems
. We are currently looking for someone to join our
Computer System Validation — CSV
area, based in
Cerdanyola del Vallès, Barcelona
. We are looking for a profile with some previous experience or knowledge in CSV, quality, laboratory environments, or computerized systems, who is willing to continue developing in a regulated and highly technical environment.

To support the validation, maintenance, and review activities of computerized systems used in the laboratory and in other company processes, ensuring compliance with applicable regulatory requirements in
GxP
environments.

• Participate in
  computer system validation
  activities, both for laboratory equipment and other systems.
• Support the preparation and review of validation documentation, such as
  Validation Plan, Risk Analysis, Design Review, IOPQ, Traceability Matrix
  , and
  Final Validation Report
  .
• Collaborate in the assessment of
  data integrity
  requirements, regulatory compliance, and change control.
• Support the preparation and execution of tests, test plans, and user acceptance testing.
• Participate in periodic reviews of computerized systems.
• Collaborate with
  Quality Assurance, IT, LIMS, and Laboratory
  teams on projects related to computerized systems.
• Support internal audits and the preparation of documentation related to CSV.

• University degree in
  Engineering, Chemistry, Physics, Pharmacy
  , or a related field.
• Previous experience, internships, or knowledge in
  computer system validation, quality, laboratory environments, IT, or regulated GxP environments
  .
• Familiarity with the computer system validation lifecycle and related documentation.
• Knowledge of regulations or guidelines such as
  GAMP 5, EU GMP Annex 11, 21 CFR Part 11, ISO, or GxP
  .
• Knowledge or experience with systems such as
  LIMS, Empower, SCADA, ERP
  , or other laboratory or corporate software.
• Ability to work collaboratively with technical departments, Laboratory, IT, and Quality Assurance teams.
• Strong organizational skills, attention to detail, and a compliance-oriented mindset.
• Advanced level of
  Spanish and English
  , both spoken and written.

• Joining a specialized and growing company.
• Professional development in a technical area with high demand within the pharmaceutical industry.
• Support and guidance from experienced Quality, Laboratory, IT, and Systems teams.
• A collaborative and dynamic work environment.
• Fl…