Computer System Validation (CSV) Engineer

Vaisesika is looking for a skilled Computer System Validation Engineer to join our team in the life sciences domain. 🧬

Job Title: Computer System Validation (CSV) Engineer.
Experience : 5 – 10 years
Location: Remote
Industry: Life Sciences 🧬
Notice : Immediate / Serving

Job Summary:

We are seeking an experienced CSV Specialist with a strong background in the life sciences domain. The ideal candidate will have at least 5 years of experience in computer system validation, with a thorough understanding of regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP5. This role requires hands-on experience in managing the validation lifecycle, producing CSV documentation, and leading assurance activities. 📑💻

JD:

➡️ Should have 5+ years of experience in computer system validation in the life sciences domain. 🕒🧬
➡️ Strong understanding of regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11 and GAMP5. 📚🔍
➡️ Proficiency in validation lifecycle documentation and processes. 📑🔄
➡️ Proficiency in change control management. ⚙️
➡️ Expertise in review and authoring end to end CSV deliverables. 🖊️📋
➡️ Good hands-on experience in Assessments, planning, assurance activities and reporting. ✅📊
➡️ Review and authoring of the qualification protocols. 📝📑
➡️ Ability to work with multiple teams and handle CSV activities single handedly. 🤝💪
➡️ Strong written and verbal communication skills. 🗣️✍️
➡️ Ability to work independently and as part of a team. ⚡👥