CSV Validation Engineer

Job Summary (List Format) :

• Minimum 5 years of experience in the life sciences industry
• Strong knowledge of Computerized Systems Validation (CSV)
• Experience drafting validation lifecycle documents (Validation Plans IQ / OQ / PQ protocols RTM VSR)
• Proficient in deviation and change management processes
• Familiarity with project management principles
• Solid understanding of 21 CFR Part 11 regulations
• Experience validating laboratory instruments
• Skilled in IT collaboration and troubleshooting
• Adept at requirements gathering and root cause analysis
• Local candidate required for hybrid on-site / remote work

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1