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S.T.B. ValiTech S.r.l. • Latina, Lazio, Italy
Salary: 11, and 21 CFR Pa
Role & seniority: CSV Engineer, mid-level (3–5 years) with independent client-facing responsibilities in validated environments.
Validation activities: FAT, SAT, IQ, OQ, PQ
Documentation: CSV Plans, Validation Reports, System Lifecycle docs, SOPs
Risk, data integrity, process mapping
Specifications: FS, HDS, SDS, CS
Tools: MS Office; travel-ready for client sites
Lead and execute qualification activities for standalone and networked computerized systems (FAT/SAT/IQ/OQ/PQ)
Develop and review validation plans/reports, risk assessments, and data integrity activities; maintain alignment with user requirements and system design
Collaborate with client stakeholders (Engineering, QA, IT, Production), review supplier-system specs, and draft/revise CSV-related SOPs
3–5 years hands-on Computer System Validation in GxP environments (pharma/biotech)
Solid knowledge of GAMP 5 and Data Integrity
Fluent Italian (mandatory); good English (written/spoken)
Degree in Engineering or a scientific field
Proficiency with Microsoft Office
Ability to travel nationwide
Experience with regulatory compliance (Annex 11, 21 CFR Part 11)
Experience with risk assessment, QA collaboration beyond core CSV tasks
Prior exposure to validation for networks and complex computerized systems
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.
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). Smart working 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.