In this role, you will work both collaboratively within cross‑functional teams – including colleagues, consultants, vendors, and MSPs – and independently to support day‑to‑day operations and project‑based initiatives. Responsibilities include supporting lab equipment and applications (GMP and non‑GMP), troubleshooting hardware and software issues, performing computer system validation activities (including change controls, validation execution, NCRs, AIRs, and CAPAs), maintaining data integrity and compliance, and administering system configuration, access management, security patching, and data backup processes. The adecuado candidate is adaptable, service‑oriented, and brings a broad technical skillset to effectively support evolving business needs.
- Execute & comply with SDLC, Change, Access, Inventory, & operational management procedures for business‑critical applications & platforms.
- Support evaluation, pilot testing, selection, & ongoing management of IT vendors & partners aligned to business & compliance requirements.
- Lead or support validation of computerized systems & laboratory instruments, including installation, configuration, troubleshooting, & documentation (SOPs, IQ/OQ/PQ).
- Ensure ongoing data integrity, backup, & regulatory compliance for GMP laboratory & manufacturing systems.
- Provide technical input & support for Investigations, Change Controls, CAPAs, decommissioning, & audit readiness activities.
- Participate in or lead Periodic Reviews, User Access Reviews, & Audit Trail Reviews for GMP systems.
- Execute & support UAT activities, collaborating with IT & business teams on issue resolution.
- Deliver hands‑on operational support for QC & Manufacturing instrument systems, including break/fix support & reliability issues in validated & production environments.
- Manage user account provisioning & deactivation in compliance with access control SOPs.
- Other duties as assigned, nothing in this job description restricts management’s right to as
📌 CSV Validation Analyst (México)
🏢 Zifo
📍 México