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

MAASI Enterprises Ltd; Emilia-Romagna; Ibrido; EUR 27.000 - 36.000; Tempo pieno

Vantaggi offerti da questo lavoro

Performance bonuses

Training programs

Equal opportunities

Descrizione del lavoro

MAASI Enterprises Ltd seeks a Junior Computerised System Validation (CSV) Specialist in the Imola area to join client-facing consulting projects in Life Sciences. Graduates or those with minimal experience are welcome to build a career in validation and regulated environments.

You will assist with Validation Plans, IQ/OQ/PQ tests, and final reports, working under senior guidance and ensuring GxP/GAMP 5 compliance. Italian and English proficiency is required; travel is at least 30%.

Competenze

• Bachelor’s or Master’s degree in Engineering or STEM disciplines with good GxP awareness.
• Native/fluent Italian and strong English (CEFR B2/C1) for drafting and multinational liaising.
• Methodological rigour, precise documentation, and proactive teamwork in regulated environments.

Mansioni

• Assist with preparation of software lifecycle deliverables (Validation Plans, Validation Reports, Traceability Matrices, URS).
• Support test protocols (IQ, OQ, PQ) for computerised systems in pharma processes.
• Review FS/DS with technical teams and update SOPs/WIs for validated systems.
• Contribute to data collection for risk assessments and impact analyses.

Conoscenze

GxP knowledge

Documentation drafting

Formazione

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

Descrizione del lavoro

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.

Working within a structured team and supported by senior colleagues, the successful candidate will:

• 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

• Location:
• Travel:
• Yes, at least 30%
• Contract Type:
• Permanent
• Working Hours:
• Mon-Fri 9-18 - Flexible hours
• Salary range:
• Annual Gross Salary from €27,000 to €36,000 + company welfare pack & performance bonus in accordance with company policy,
• Department:
• Quality Assurance, Life Science
• Reporting to:
• We offer an excellent growth opportunity

Main responsibilities

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.

Requirements

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.
Methodological rigour, precision in documentation, strong problem-solving mindset, and a proactive attitude towards teamwork in regulated environments.

Nice to have

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).
Strong passion for the IT field.

What We Offer

A comprehensive training program that includes:

• Internal and external training programs.
• Performance bonuses.

MAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life.

We believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit.

Rewarding

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

Trainings

Internal and external trainings specifically selected on your aptitudes and talent.

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. You'll never be "just a number" here.