CSV Specialist (M/F) - Pharmaceutical Industry

Fortil Switzerland SA; Brussel Hoofdstad; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

High-value project opportunities

Dynamic work environment

Fast-track skill development

Résumé du poste

Fortil Switzerland SA is seeking a CSV Specialist to ensure compliance of computerized systems within the pharmaceutical industry. In this role, you will lead Computer System Validation (CSV) activities, manage validation documentation, and collaborate cross-functionally to uphold regulatory standards.

The ideal candidate has a degree in Computer Science or a related field, along with 3 to 7 years of experience in CSV. You will be working in a challenging environment that promotes fast-track skill development and career growth.

Qualifications

• 3 to 7 years of experience in Computer System Validation (CSV) within the pharmaceutical or biotech industry.
• Strong knowledge of GAMP5, GMP, FDA 21 CFR Part 11, ICH, EU guidelines.
• Professional level of English (written and spoken).

Responsabilités

• Execute and lead Computer System Validation (CSV) activities in compliance with GAMP5, GMP, and 21 CFR Part 11.
• Prepare and manage validation documentation: validation plans, risk assessments, test strategies, and protocols.
• Collaborate with cross-functional teams to ensure compliance with regulations.

Connaissances

Computer System Validation (CSV)

GMP knowledge

Regulatory compliance

Cross-functional teamwork

Attention to detail

Formation

Bachelor’s or Master’s degree in Computer Science, Engineering, or related scientific field

Outils

LIMS

CDS

BMS

SAP

JDE

Description du poste

Fortil is an international engineering and technology consulting group, built on an independent model and bringing together over 2,500 employees across 14 countries. Fortil fosters an entrepreneurial mindset and empowers individuals to unlock their full potential.

YOUR ROLE

As part of projects in the pharmaceutical industry, you will act as a CSV Specialist, ensuring that computerized systems comply with regulatory requirements.

Your main responsibilities will include:

• Execute and lead Computer System Validation (CSV) activities in compliance with GAMP5, GMP, and 21 CFR Part 11.
• Prepare and manage validation documentation: validation plans, impact assessments, URS, risk assessments, test strategies, protocols, SOPs, and periodic reviews.
• Validate computerized systems and equipment (laboratory, manufacturing, IT systems).
• Ensure data integrity and perform Excel validation in a GMP environment.
• Collaborate with cross-functional teams (IT, Quality, Manufacturing, Laboratory).
• Ensure compliance with US, EU, and ICH regulations.
• Contribute to continuous improvement of validation processes.

PROFILE

• Bachelor’s or Master’s degree in Computer Science, Engineering, or related scientific field (or equivalent experience in GMP environment).
• 3 to 7 years of experience in Computer System Validation (CSV) within the pharmaceutical or biotech industry.
• Strong knowledge of regulations: GAMP5, GMP, FDA 21 CFR Part 11, ICH, EU guidelines.
• Familiarity with systems such as LIMS, CDS, BMS, SAP, JDE.
• Understanding of project lifecycle and software validation processes (SDLC).
• Professional level of English (written and spoken).

Soft skills

• Strong attention to detail and rigor
• Ability to work cross-functionally
• Autonomy and ability to manage multiple priorities
• Excellent communication and presentation skills

WHAT WE OFFER

• Opportunity to work on high-value projects in the pharmaceutical industry
• A challenging and dynamic environment alongside technical experts
• Fast-track skill development in validation and regulatory compliance
• Fortil culture focused on performance, autonomy, and career growth