Computer System Validation (CSV) Engineer

S.T.B. ValiTech S.r.l.; Latina; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Meal vouchers

Company car

Smart working enabled

Job summary

S.T.B. ValiTech S.r.l. in Italy is seeking an experienced CSV Engineer to manage validation deliverables for complex computerized systems in highly regulated environments. 3-5 years of hands-on experience and independence with clients are expected.

You will ensure compliance with GAMP 5, Annex 11, and 21 CFR Part 11, draft validation plans and reports, and collaborate with Engineering, QA, IT, and Production to ensure successful project delivery.

Qualifications

• 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.

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 FS, HDS, SDS, and CS as provided by suppliers or system developers.
• Ensure alignment between user requirements, system design, and validation deliverables.

Skills

GAMP 5

Data Integrity

Microsoft Office

Education

Bachelor's or Master's in Engineering or sciences

Job description

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).
• 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.