CSV Engineer: Remote-Ready, Nationwide Travel & Growth

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

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.