Computer System Validation (CSV) Engineer

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.

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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:

Because this role is based at an Italian client site, candidates must meet the following criteria:

• 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).
• Smart working authorized by the company for CSV activities suitable for remote execution.
• Continuous professional development and long-term career progression. xdwybme
• Exposure to top-tier industry clients and innovative technologies.