CSV Specialist (MF) Pharmaceutical Industry

Fortil is an international engineering and technology consulting group built on an independent model and bringing together over 2500 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

• Bachelors or Masters 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