CSV Validation Engineer
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Job Location:
Summit, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
9 days ago
Vacancies:
1 Vacancy
Job Summary
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
- 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
