Junior CSV Consultant

Abylsen; Monza; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

A leading engineering consulting group in Lombardia is seeking a Junior CSV Consultant for the Lifesciences Sector. This role involves validating computerized systems, ensuring compliance with GMP / GxP regulations, and preparing technical documentation. Candidates should have at least 2 years of relevant experience, strong knowledge of regulatory frameworks, and fluency in Italian. The company offers a permanent contract, health care assistance, and access to gyms throughout Italy, promoting an inclusive work environment.

Servizi

Permanent contract

Supplementary health care assistance

Free access to +500 gyms throughout Italy

Competenze

• Minimum 2 years of experience in Equipment Validation and Computer System Validation.
• Strong knowledge of GMP / GxP regulations, Annex 11, and FDA 21 CFR Part 11.
• Ability to prepare validation documentation.

Mansioni

• Perform validation of computerized systems in lab and production.
• Ensure compliance with GMP / GxP regulations.
• Prepare and manage validation documentation.

Conoscenze

Experience in Equipment Validation

Knowledge of GMP / GxP regulations

Technical documentation preparation

Familiarity with laboratory equipment

Fluency in Italian

Strumenti

HPLC

Weighing systems

Incubators

Descrizione del lavoro

ABYLSEN

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 ambition 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

Junior CSV Consultant

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 (URS, IQ / OQ / PQ).
• Collaborate with QC, Production, and R&D teams for onsite operational support.

Requirements

• Proven experience (2 years at least preferably) in Equipment Validation and Computer System Validation (CSV).
• Strong 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! 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.

This announcement is addressed to both sexes, in accordance with Laws 903 / 77 and 125 / 91, and to people of all ages and nationalities, in accordance with Legislative Decrees 215 / 03 and 216 / 03