Computerized System Validation (CSV) Senior Specialist
Duchnice, PL
Join Rezon Bio, where biotech experts create biologics that improve lives worldwide - not by following the old rules, but by finding better, more reasonable ways to do things.
Built on the excellence of Polpharma Biologics, Rezon Bio is evolving into a Contract Development and Manufacturing Organization (CDMO) with a clear reason: to challenge the status quo and raise the bar in biotech.
With state-of-the-art centers in Gdańsk and Warsaw-Duchnice, we offer career opportunities across science, technology, and business for those who want their work to truly resonate.
Work alongside 1,300 professionals who combine global ambitions with local roots – driven by science, purpose, innovation, and respect for diversity.
If you have hands-on experience in Computerized System Validation (CSV) and want to shape innovative projects that meet the highest GMP standards, this role is for you. Join an experienced team, influence how advanced digital solutions are implemented, and see your work translate directly into patient impact. Apply today!
Your responsibilities:
- Plan, execute, and document validation of new and existing computerized systems.
- Create and maintain CSV procedures, work instructions, and templates across the system lifecycle.
- Ensure qualification/validation activities comply with current GxP, 21 CFR Part 11, and EU Annex 11.
- Prepare complete CSV deliverables (e.g., validation plans, risk assessments, protocols, test records, reports).
- Provide expert CSV guidance to project teams from selection and implementation through operation and change control.
- Support and host regulatory and client audits/inspections.
- Manage vendors and service providers for CSV activities and system deliveries.
- Monitor regulatory changes and introduce effective methods and tools to continuously improve CSV practices.
Our expectations:
- Higher education (bachelor's or master's degree) in chemistry, biotechnology, automation, robotics, IT, or a related field, or equivalent professional experience.
- A minimum of 5 years of experience working with computerized systems in a regulated environment.
- Strong knowledge of GMP requirements, FDA regulations, 21 CFR Part 11, and EU Annex 11.
- Experience in developing validation documentation and managing computerized systems.
- Ability to diagnose and solve problems.
- Excellent organizational skills and stress resilience.
- Fluency in English, both spoken and written.
We offer:
- Work at a leading Polish biotechnology company and make a real impact by enabling breakthrough therapies for patients worldwide.
- Collaboration with experts from leading biotechnology companies globally.
- Private medical care.
- Life insurance.
- Employee Pension Program (PPE).
- Annual and special occasion bonuses.
- Financial support for skills development.
- Flexible benefits package.
- One additional day off per year (Polpharma Day).
- And much more.
We fuel your professional growth and back it with a comprehensive benefits package. Our advanced facilities support both commercial-scale production and cutting-edge R&D, making us one of the most modern biotech organizations in Europe.
Here your ideas resonate and drive meaningful change. With continuous learning opportunities, many experts have already found their reason to return or relocate to Poland and grow their careers with us.
Does this resonate with you?
Learn more at RezonBio.com/careers and on LinkedIn