CSV Consultant

fortil; Milano; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

An international engineering consultancy is seeking a CSV Consultant for a strategic project in Milan. This role involves validating computerized systems in the Life Science sector and requires a technical background with over 3 years of experience in CSV projects. Strong knowledge of regulations such as GMP and CFR 21 Part 11 is essential. The position offers full-time employment and a supportive development environment.

Servizi

Personalized support for skill growth

Opportunities for shareholding

Community and non-profit project involvement

Policy to support parenthood

Competenze

• 3+ years of experience on CSV projects in the Life Science field.
• Skilled in mapping data flows and performing gap analyses.
• Knowledge of FDA 21 CFR part 11 regulations and guidelines.

Mansioni

• Validate computerized systems in the Life Science sector.
• Support management of remediation or requalification projects.
• Draft validation documents and execution protocols.

Conoscenze

CSV project experience

Data flow mapping

Compliance analysis

Knowledge of regulations (GMP, CFR 21 Part 11)

Good knowledge of English

Office package proficiency

Formazione

Bachelor's or Master's degree in engineering or similar

Descrizione del lavoro

Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.

We are looking for a CSV Consultant for a strategic project.

Responsibilities

• Validation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines;
• Support in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines;
• Periodic review of computerized systems and user audit trails;
• Drafting of validation documents: Validation Plans, URS, Traceability Matrices;
• Drafting and execution in the field of test protocols: IQ/OQ/PQ;
• Drafting of Risk Assessments;
• Drafting of computerized system administration procedures;

About You

• Bachelor's or Master's degree in technical‑engineering or similar subjects (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology);
• 3+ years of experience on CSV projects in the Life Science field;
• Skilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities;
• Good knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5; guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICHQ9, is required;
• Good knowledge of the English language, both written and spoken;
• Excellent knowledge of the Office package;

At Fortil, we implement concrete initiatives to support your development and ensure an inspiring work environment:

• Personalized support to help you grow your skills
• An ecosystem that encourages you to step outside your comfort zone
• The opportunity to become a shareholder
• Involvement in community and non‑profit projects
• A dedicated policy to support parenthood

Fortil is committed to equal opportunity. All our positions are open to people with disabilities, regardless of gender, origin, or sexual orientation.

Seniority level

• Entry level

Employment type

• Full‑time

Job function

• Consulting

Industries

• IT Services and IT Consulting