CSV Engineer

EFOR (formerly CVO-Europe); Wallonië; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

EFOR is seeking a CSV Engineer in Belgium to validate and maintain computerized systems in a GMP/GxP environment. You will define validation strategies and manage documentation across the lifecycle.

You will collaborate with Quality, IT, Engineering and Production teams to ensure continued validated status, data integrity, and adherence to 21 CFR Part 11 and EU Annex 11 where applicable.

Qualifications

• Degree in Engineering, IT, Life Sciences or Pharmacy.
• Experience in Computerized System Validation (CSV) in regulated environments.
• Knowledge of GMP/GxP requirements and Data Integrity.

Responsabilités

• Defining and implementing Computerized System Validation strategies.
• Preparing, reviewing and executing validation documentation (URS, Risk Assessments, Validation Plans, IQ, OQ, PQ, Validation Reports).
• Performing GxP and system impact assessments.
• Defining and executing risk-based validation approaches.
• Reviewing and approving test protocols, results and validation evidence.
• Managing deviations, discrepancies and CAPAs related to validation activities.
• Assessing system changes and ensuring continued validated status through change control.
• Supporting Data Integrity and compliance assessments.
• Ensuring GMP/GxP compliance and industry standards.
• Collaborating with Quality, IT, Automation, Engineering, Production, system owners and suppliers.
• Supporting computerized systems lifecycle from implementation to operation and retirement.

Connaissances

Engineering

IT

Computerized System Validation

GMP/GxP

Data Integrity

GAMP 5

21 CFR Part 11

Teamwork

Formation

Engineering degree (Life Sciences, IT, or equivalent)

Pharmacy or Life Sciences background

Outils

URS

IQ/OQ/PQ

Description du poste

Efor is a leading consulting group specialized in Life Sciences, bringing together more than 3,200 consultants and experts and supporting over 1,000 clients worldwide, including 90% of the leading pharmaceutical, biotechnology and medtech companies.

In Belgium, our teams contribute to high-impact projects for major Life Sciences players such as UCB, GSK, Novo Nordisk, Takeda and Baxter, addressing key challenges across CQV, Quality, and Engineering.

As part of our continued growth in Belgium, we are looking for CSV Engineers who want to bring their expertise to ambitious pharmaceutical and biotechnology projects and contribute to the validation and compliance of critical computerized systems.

Your role

As a CSV Engineer, you will work at the heart of our clients’ projects, ensuring that computerized systems are validated and maintained in a compliant state throughout their lifecycle, in accordance with GMP, GxP and Data Integrity requirements.

• Defining and implementing Computerized System Validation strategies;
• Preparing, reviewing and executing validation documentation such as URS, Risk Assessments, Validation Plans, IQ, OQ, PQ and Validation Reports;
• Performing GxP and system impact assessments;
• Defining and executing risk-based validation approaches;
• Reviewing and approving test protocols, test results and validation evidence;
• Managing deviations, discrepancies and CAPAs related to validation activities;
• Assessing system changes and ensuring continued validated status through change control;
• Supporting Data Integrity and compliance assessments;
• Ensuring compliance with applicable GMP/GxP requirements and industry standards;
• Collaborating with key stakeholders including Quality, IT, Automation, Engineering, Production, system owners and suppliers;
• Supporting computerized systems throughout their lifecycle, from implementation to operation and retirement.

Your profile

• A scientific or technical degree in Engineering, IT, Computer Science, Life Sciences, Pharmacy or equivalent;
• First successful experience or several years of experience in Computerized System Validation (CSV) within a regulated environment;
• Previous experience within the pharmaceutical or biotechnology industry;
• Good understanding of GMP / GxP requirements and Data Integrity principles;
• Knowledge of the computerized system validation lifecycle and associated documentation;
• Familiarity with GAMP 5 and risk-based validation principles;
• Knowledge of 21 CFR Part 11 and EU Annex 11 is a strong asset;
• Ability to work effectively within multidisciplinary teams involving Quality, IT, Engineering, Automation and Business stakeholders;
• Strong analytical skills, autonomy, attention to detail and a quality-driven mindset;
• Good command of English; French and/or Dutch is an asset depending on the project.

What makes EFOR different?

At EFOR, our consultants are never on their own.

You become part of a genuine ecosystem of expertise, designed to help you make a meaningful impact on the projects you contribute to:

A strong community of consultants and experts to share knowledge, discuss technical challenges and leverage field experience;

A Knowledge Management environment designed to develop, structure and share expertise across the Group;

Digital & AI tools supporting our consultants in tackling complex challenges more efficiently;

A career path tailored to your ambitions, whether you want to deepen your technical expertise or progress towards coordination, project management, subject matter expertise or leadership roles;

A wide variety of projects and technical environments with leading pharmaceutical and biotechnology companies.

Our ambition goes beyond placing you on a project: we want to give you the environment, expertise and opportunities to grow and build your career over the long term.