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Computerized System Validation (CSV) Senior Specialist
Rezon BioOżarów Mazowiecki, Województwo mazowieckie, Polska4 dni temu
Opis pracyHigher 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. 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.
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 :
We offer :
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