Computerized System Validation (csv) Senior Specialist (female/male) (duchnice)
Rezonbio
Duchnice, PL
On-site
Computerized system validation (csv)
Gmp compliance
21 cfr part 11 knowledge
Join an experienced team, influence how advanced digital solutions are implemented, and see your work translate directly into patient impact
Job Summary
Join an experienced team, influence how advanced digital solutions are implemented, and see your work translate directly into patient impact.
Work at a leading Polish biotechnology company and make a real impact by enabling breakthrough therapies for patients worldwide.
Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles regardless of gender, age, orientation, gender identity, or other individual characteristics.
Matching Summary
Join an experienced team, influence how advanced digital solutions are implemented, and see your work translate directly into patient impact.
Skills & Requirements
Must-have
Computerized System Validation (CSV)
GMP compliance
21 CFR Part 11 knowledge
EU Annex 11 compliance
Validation documentation development
Regulated environment experience
Nice-to-have
Problem diagnosis and resolution
Organizational skills
Stress resilience
Fluency in English
Vendor management
Regulatory audit support
Key Requirements
Minimum 5 years experience in regulated environment
Higher education in chemistry, biotechnology, automation, robotics, IT or related field