CSV (Computer System Validation) Engineer

About Us:  

Synergia Compliance Systems provides innovative and flexible digital quality and manufacturing solutions for companies in the life sciences and regulated industries. We help organizations streamline compliance with global standards (GMP, FDA, ISO) through smart, configurable platforms.

Job Description:  

We are seeking a skilled and motivated CSV Engineer to join our growing team in Kfar Saba. You will be responsible for validating computerized systems used in regulated environments (GxP), supporting client implementations, and ensuring compliance with industry regulations.

Responsibilities:  

- Prepare and execute validation documentation (URS, IQ, OQ, PQ, risk assessments)  

- Work with project teams to ensure validation requirements are met  

- Perform gap analyses and system assessments  

- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and relevant ISO standards  

- Support audits and inspections  

- Collaborate with QA and IT teams  

- Handle scope, risk, and change management.

Requirements:

- 2+ years of experience as a project manager, preferably in life sciences or regulated industries.

- Strong understanding of quality standards and regulatory frameworks (pharma/medical device).  

- Excellent communication skills and customer-oriented approach.  

- Ability to work independently and manage multiple priorities.  

- Fluent in English and Hebrew.

Why Join Us?  

At Synergia Compliance Systems, we develop smart and flexible digital platforms that help life science companies stay compliant and efficient. You'll join a team that values innovation, professionalism, and a supportive work environment. As a fast-growing company, we offer opportunities for professional growth, hybrid work options, and a meaningful impact on clients that save lives.