Job Description – GxP IT & CSV Engineer – L2

Position: GxP IT & CSV Engineer – L2
Experience: 3–4 Years
Location: Ahmedabad
Employment Type: Full-Time

Note: We are looking for an Ahmedabad Local Candidates

Job Summary:

We are looking for a GxP IT & CSV Engineer – L2 with strong experience in IT Infrastructure, GxP applications, Computer System Validation (CSV), and IT compliance. The candidate will be responsible for managing GxP applications, infrastructure, validation activities, SOPs, audits, and L2 technical support while ensuring compliance with applicable GxP and Site QMS requirements.

Key Responsibilities: GxP & CSV:

- Administer and support GxP application software and related IT systems.
- Prepare, execute, review, and maintain CSV documentation and validation documents.
- Prepare, execute, and/or review CSVMP (Computer System Validation Master Plan) documents.
- Prepare and review software qualification documents, including challenge tests and supporting documentation.
- Ensure implementation and adherence to GxP practices related to IT at the site.
- Prepare and review SOPs and SOP attachments and ensure their adherence.
- Maintain training records for applicable SOPs and GxP activities.
- Follow Site QMS procedures and maintain required documentation.

IT Infrastructure & L2 Support:

- Perform L2 troubleshooting and technical support for servers, systems, applications, and network components.
- Administer and maintain Windows Servers, Active Directory, and IT infrastructure.
- Perform server log and alert monitoring, space management, hardening, and AD policy implementation.
- Manage infrastructure patching and security updates.
- Perform backup and restoration activities, including execution, verification, and documentation.
- Monitor Data Centre infrastructure and ensure system availability.
- Install, configure, and commission servers, systems, software, and network components.




- Perform application administration and provide technical support for GxP systems.
- Implement and ensure adherence to desktop and IT policies.

IT Operations & Project Management:

- Manage inventory of GxP applications and IT infrastructure.
- Monitor defined SLA requirements and evaluate vendor performance.
- Track, analyse, and manage Change Requests.
- Support IT infrastructure projects, new implementations, and site initiatives.
- Act as Site IT Lead wherever applicable.
- Coordinate with vendors, service engineers, and internal teams for IT-related activities.
- Provide training and technical support to end users and service engineers.

Audit & Compliance:

- Support and respond to internal and external audits and compliance requirements.
- Coordinate with auditors and regulators and provide technical explanations/documentation when required.
- Ensure proper documentation and adherence to GxP, QMS, SOP, and IT compliance requirements.
- Maintain compliance records and ensure timely closure of audit observations and action items.

Required Skills & Knowledge:

- Strong knowledge of L2 IT Infrastructure Support.
- Hands-on experience with Server Administration and Active Directory.
- Good knowledge of Networking, Backup & Restore, Patch Management, and Data Centre Operations.
- Strong understanding of Computer System Validation (CSV).
- Knowledge of GxP / GMP / GLP / GCP environments.
- Experience in SOP, QMS, Change Control, Validation, and Audit Compliance.
- Knowledge of IT systems used in Pharmaceutical / Life Sciences environments.
- Good documentation, analytical, troubleshooting, and communication skills.

Preferred Experience:

- Experience working in a Pharmaceutical / Life Sciences / GxP workplace.
- Hands-on experience in both IT Infrastructure L2 Support and CSV/Validation activities.
- Exposure to regulatory audits and compliance requirements will be an added advantage.

Candidates with experience in GxP Application Support + CSV + Infrastructure will be preferred.

Pay: From ₹40,000.00 per month

Work Location: In person

📌 GxP IT & CSV Engineer – (India)
🏢 Hyperlink ITSystem
📍 India