Computerised System Validation Specialist Junior (Imola area, BO, Italy)

We are looking for a Junior CSV Specialist (Computerised System Validation) to join our team on client-facing consulting projects within the Life Sciences sector. This position is open to graduating students, recent graduates, or candidates with minimal experience eager to build a career in consulting.

Support the definition and drafting of Validation Plans and related documentation deliverables

Collaborate on the design, implementation, and execution of test protocols (IQ, OQ, PQ)

Collect, analyse, and track test evidence, and draft final validation reports

Assist the client throughout the entire lifecycle of the computerised system in compliance with GxP and GAMP 5 regulations

Contract Type:

Permanent

Mon-Fri 9-18 - Flexible hours

Annual Gross Salary from €27,000 to €36,000 + company welfare pack & performance premio in accordance with company policy,

Quality Assurance, Life Science

Working alongside and under the guidance of senior consultants, the successful candidate will be progressively involved in the following activities:

Assisting with the preparation of software lifecycle deliverables, including Validation Plans, Validation Reports, Traceability Matrices and User Requirements Specifications (URS).

Supporting the preparation and execution of test protocols (IQ, OQ, PQ) for computerised systems and software solutions supporting pharmaceutical processes.

Participating in the review of Functional Specifications (FS)



and Design Specifications (DS), working closely with technical and process teams.

Supporting the updating and review of Standard Operating Procedures (SOPs) and Work Instructions (WIs) relating to validated systems or systems undergoing validation.

Contributing to data collection for technical Risk Assessments and Impact Assessments.

Bachelor’s or Master’s degree in Engineering (Biomedical, Management, Computer Science, Chemical), Biotechnology, Pharmaceutical Chemistry and Technology (CTF, Computer Science, or equivalent STEM disciplines.

Basic knowledge of or strong interest in GxP principles, GAMP 5, and guidelines for validated systems (FDA 21 CFR Part 11, EU Annex 11);

Native/fluent Italian and good/excellent working knowledge of English (minimum CEFR B2/C1 level), required for drafting documentation and liaising within multinational environments.

Prior experience or internship within the Life Sciences consulting sector.

Familiarity with GxP principles, GAMP 5, and guidelines for validated systems (FDA 21 CFR Part 11, EU Annex 11).

A comprehensive training program that includes:

Internal and external training programs.

Performance bonuses.

A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base.

A set of benefits, services and affiliations on top to the profession's health insurance.

we're Humans

We're a Company of human beings, before anything else.

📌 COMPUTER SYSTEM VALIDATION SPECIALIST JUNIOR (Emilia-Romagna)
🏢 MAASI Enterprises
📍 Emilia-Romagna