CSV Consultant

fortil; Aprilia; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading engineering consulting group in Aprilia seeks a Computer System Validation Consultant to validate computerized systems in the Life Science sector. The ideal candidate will have experience with GxP regulations, drafting validation documents, and a relevant technical degree. Positive company culture emphasizes excellence and social responsibility, making it a great place for skilled professionals eager to contribute to impactful projects.

Competenze

• 1+ years of experience in relevant fields.
• Knowledge of GxP regulations and GAMP Guidelines.
• Experience in validation documentation and test protocol drafting.

Mansioni

• Validate computerized systems in the Life Science sector.
• Support remediation projects for compliance with FDA and EU regulations.
• Draft validation documents and protocols, including Risk Assessments.

Conoscenze

Mapping data flows

Gap analyses for compliance

Good knowledge of English

Excellent knowledge of Office package

Formazione

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

Descrizione del lavoro

Fortil is an engineering consulting group active across Europe since 2009. We support our partners in the success of their technical projects in various sectors such as Industry, IT, and Care.

Today, we are more than 2,700 employees across 11 countries. Working with us means being part of an ambitious team in a multicultural and international environment!

Our ambition is to help build a more responsible, supportive and inclusive world for our employees and clients.

We are currently seeking a Computer System Validation (CSV) Consultant to join our growing team inAprilia.

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);
• We consider candidates with various levels of seniority,1+ years of experience;
• Skilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities;
• Good knowledge of the English language, both written and spoken;
• Excellent knowledge of the Office package;

Next Steps

• Someone from the Talent Acquisition department will contact you to schedule an initial HR interview.
• If successful, a second interview will be conducted to validate your technical knowledge.
• In case of a positive outcome from the technical interview, there will be a last qualification meeting with the Client.
• If the final outcome is positive, we will discuss our proposal with you. Alternatively, if the outcome is negative, we will share our sincere feedback!
  
  

Why Fortil?

Although we currently find ourselves in a significant phase of expansion, the high standards of our projects and recruitments remain as demanding as ever. Quality will always take precedence over quantity, as we prefer excellence to ease!

We hope to become the largest independent engineering group in Europe, working to serve future generations. To do so, our operational model is based on four fundamental aspects:

• Profitable performance
• Expert engineers
• Efficient organisation
• Social responsibility
  
  

Apply and join us to become part of a model that is out of the ordinary!