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fortil · 3 months ago

CSV Engineer

San Diego, CA

Full-time

Onsite

Mid Level

Fortil is an international engineering and technology consulting group with over 2,500 employees worldwide. They are seeking a CSV Engineer to define and implement the Computerized System Validation strategy, ensuring compliance with industry standards and acting as a liaison with clients and suppliers.

ConsultingFinanceInformation Technology

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Defining and implementing the Computerized System Validation (CSV) strategy

Taking ownership of all or part of the following activities:

Validation of automated systems, SCADA, and MES (Manufacturing Execution Systems)

Drafting functional analyses

Writing test protocols, change control documents, and validation reports

Executing IQ, OQ, PQ qualification tests

Ensuring compliance with GAMP, 21 CFR Part 11, and GxP standards

Acting as a liaison with suppliers and/or clients

Qualification

Computerized System ValidationGAMP guidelines21 CFR Part 11BPF/GMP knowledgeTest case drafting

Required

Master's degree (Bac+5) in a scientific field, engineering school, or pharmacy

Previous experience in a similar role

Strong knowledge of BPF/GMP, 21 CFR Part 11, GAMP guidelines and regulations related to computerized system validation

Experience in drafting test cases and participating in qualification test execution

Genuine desire to develop your expertise and strengthen any missing technical skills

Benefits

Personalized career development and upskilling programs.

An ecosystem that challenges your comfort zone.

The opportunity to become a shareholder of the company.

Involvement in social and community projects.

A dedicated parenthood policy promoting work–life balance.

Company

fortil

Glassdoor4.2

Fortil is an engineering is a technology consulting company that specializes in data development, engineering, consulting and finance.

Founded in 2009

La Seyne-sur-mer, Provence-Alpes-Cote d'Azur, FRA

1001-5000 employees

https://www.fortil.group

H1B Sponsorship

fortil has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (1)

Funding

Current Stage

Late Stage

Leadership Team

Olivier Remini

Founder and CEO

Company data provided by crunchbase