CSV Validation Analyst

Zifo•Emeryville, CA

1d•Hybrid

About The Position

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. The primary focus of the role is managing daily operational activities, including Tier 1 and Tier 2 IT Helpdesk support for end users and customers. 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 ideal candidate is adaptable, service-oriented, and brings a broad technical skillset to effectively support evolving business needs. Hybrid schedule acceptable with a desire for 3-4 days onsite weekly.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field with at least 5+ years of relevant experience in a laboratory environment or biotech/pharma setting; or Master’s degree with 3–5+ years of relevant experience
Strong operational knowledge of laboratory IT environments, including instrument connectivity & client/server architectures.
Proficiency in Windows OS administration (registry, system files, security, local accounts & policies).
Working knowledge of network technologies (VLANs, firewalls, security protocols, instrument LANs).
Familiarity with virtualization platforms (e.g., VMware, Citrix VDI).
Experience supporting validated systems in a regulated GxP environment is required.
Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process
Familiarity with broad range of lab instrumentation and Enterprise IT solutions used in Biopharma, e.g., LC systems (Waters/Agilent), AKTA, SoftMaxPro, Geneious, ELN/LIMS (Sapio), Imaging Systems, Bioreactors, Plate readers, Sequencers, etc.

Responsibilities

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 assign or reassign duties and responsibilities to this job at any time