WE ARE HIRING | AI & COMPUTER SYSTEM VALIDATION (CSV) SPECIALIST

Work Mode: Work from Office
Shift Timing: 2:00 PM – 11:00 PM IST
Experience: 5–8 Years
Industry: Life Sciences / Pharmaceuticals / Biotechnology
Client: Thermo Fisher Scientific

We are looking for an experienced AI & Computer System Validation (CSV) Specialist with solid hands-on expertise in Artificial Intelligence and Computer System Validation within a GxP-regulated environment.

Key Skills & Responsibilities

1. Artificial Intelligence (Mandatory)

- Hands-on experience with AI, Generative AI, Machine Learning, or AI-enabled applications.
- Experience applying AI to validation documentation, requirements analysis, test-case generation, and process automation.
- Ability to evaluate and validate AI-enabled applications in regulated environments.
- Understanding of AI-related risks, including accuracy, data privacy, explainability, hallucinations, and model performance.

2. Computer System Validation (Mandatory)

- Strong experience in end-to-end Computer System Validation (CSV) activities in GxP environments.
- Expertise in validation documentation, including URS, FRS, risk assessments, and validation plans.
- Experience in IQ/OQ/PQ testing, test scripts, test protocols, and Requirements Traceability Matrix (RTM).
- Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11,



and applicable GxP regulations.
- Experience in deviation management, change control, CAPA, audit readiness, and validation lifecycle documentation.

3. Tools & Additional Skills

- Familiarity with ALM, DMS, Jira, Azure DevOps, HP ALM/Quality Center, or equivalent tools.
- Strong analytical, documentation, communication, and stakeholder-management skills.
- Business Analysis knowledge, including requirements gathering and process analysis, will be an added advantage.

Mandatory Requirements

✅ 5–8 years of relevant experience in Life Sciences / Pharma / Biotechnology or other GxP-regulated industries.

✅ Hands-on AI experience is mandatory.

✅ Strong Computer System Validation (CSV) expertise is mandatory.

✅ Willingness to work from office and support the 2:00 PM – 11:00 PM IST shift.

Interested candidates: Please share your updated resume to [email protected]

Pay: ₹100,000.00 - ₹150,000.00 per month

Application Question(s):

- Will you work from Bengaluru?
- The exp CTC is 1 Lakh to 1.5 Lakh per month. Are you fine with this?
- Will you join with in 15 days ?
- How many years of exp in AI & CSV?
- How many years of exp in Life Sciences / Pharma / Biotechnology or other GxP-regulated industries.?

Work Location: In person

📌 AI & COMPUTER SYSTEM VALIDATION (CSV) SPECIALIST (Bengaluru)
🏢 Advancesoft India
📍 Bengaluru