ABYLSEN
Verifichi che le sue competenze e la sua esperienza corrispondano ai requisiti di questo ruolo, quindi si candidi con il suo CV qui sotto.
is an international engineering consulting group with 3300 employees and a turnover of 290 M€ in 2023. Created by a number of entrepreneurs in 2005, the group was born from a common development ambitions across the major European regions and is now located in 30 locations spread over 7 countries (France, Italy, Switzerland, Spain, Luxembourg, Belgium and Netherlands).
As a multi-specialist, we are active in 8 main business sectors (Automotive, Aeronautics, Rail, Heavy Industry, Energy, IT/Telecom, Lifesciences, Banking/Finance) and bring our expertise to all our clients on their innovation projects R&D and operational performance.
As part of the development of our entity Abylsen Italy, specialized in Transport (automotive, aeronautics, defense, space and rail), Heavy Industry (metallurgy, steel plant), Energy and IT, we are looking for a
CSV Specialist
in the Lifesciences Sector to integrate our team of consultants and bring your expertise on all our projects.
What is the challenge?
MAIN ACTIVITIES:
Perform validation of computerized systems integrated into laboratory and production equipment.
Ensure compliance with GMP/GxP regulations and international guidelines.
Prepare and manage validation documentation.
Collaborate with QC, Production, and R&D teams for onsite operational support..
REQUIREMENTS
:
Proven experience (2/4 years preferably) in
Computer System Validation (CSV)
.
Knowledge of
GMP/GxP regulations
,
Annex 11
, and
FDA 21 CFR Part 11
.
Ability to prepare technical documentation (URS, IQ/OQ/PQ).
Familiarity with laboratory and production equipment (e.g., HPLC, weighing systems, incubators with software).
Fluency in
Italian is mandatory
.
WE OFFER
:
Permanent contract
Supplementary health care assistance "Fondo Est"
Free access to +500 gyms throughout Italy
Periodic follow up with Business Managers
Beyond your technical knowledge, it is really your personality that will make the difference !
No barrier should hold talent back! xivgfpx Committed to equal opportunities, our Group is part of an inclusive approach: every position is open to everyone, and we actively support the integration of people with disabilities.