About S.
T.
B. ValiTech Founded in 2004, S.
T.
B. ValiTech is a company in continuous expansion, with over 200 employees, specializing in equipment qualification, industrial calibration, Computer System Validation (CSV), Clean & Black Utilities, and electro‑instrumental design and installation. With headquarters in Sabaudia and a newly opened office in Milan (Rho), we support major Life Sciences organizations, across Italy and abroad, with high‑quality, reliable and innovative technical services.

About the Role
We are seeking a CSV Engineer with proven experience to manage validation deliverables for complex computerized systems in highly regulated environments. This position is ideal for candidates with 3-5 years of experience that works independently with clients and ensures full compliance with GAMP 5, Annex 11, and 21 CFR Part 11. Responsibilities
* Lead and execute qualification activities (FAT, SAT, IQ, OQ, PQ) for standalone and networked computerized systems.
* Draft and review System Configuration and system lifecycle documentation.
* Develop Computer System Validation Plans and Validation Reports.
* Drive Risk Assessment activities (RA, Data Integrity, Process Mapping).
* Write and revise SOPs related to CSV and Data Integrity.
* Collaborate directly with client stakeholders (Engineering, QA, IT, Production).
* Review Functional Specifications (FS),



Hardware Design Specifications (HDS), Software Design Specifications (SDS), and Configuration Specifications (CS) provided by suppliers or system developers.
* Ensure alignment between user requirements, system design, and validation deliverables. Requirements
* Bachelor’s or Master’s degree in Engineering or scientific fields is required.
* 3-5 years of hands‑on experience in Computer System Validation within pharmaceutical, biotech, or other GxP‑regulated industries.
* Solid knowledge of GAMP 5 and Data Integrity principles.
* Proficiency in Microsoft Office.
* Availability to travel nationwide based on project requirements. Language

Requirements:
* Fluent Italian (mandatory)
* Good English knowledge (written and spoken) Note: Applications from candidates who do not speak Italian cannot be considered.

What We Offer
* Competitive compensation based on experience.
* Meal voucher / client’s canteen.
* A company car is available for client‑site travel and can be picked up from our headquarters in Sabaudia (LT).
* Lavoro da remoto authorized by the company for CSV activities suitable for remote execution.
* Continuous professional development and long-term career progression.
* Exposure to top-tier industry clients and innovative technologies. #J-18808-Ljbffr

📌 Computer System Validation (Latina)
🏢 S.T.B. VALITECH
📍 Latina