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Job Description
CSV Validation Analyst Zifo Emeryville, CA Job Details Full-time 15 hours ago Benefits Health insurance Dental insurance Flexible spending account Vision insurance 401(k) matching Life insurance Qualifications Quality control corrective actions Data integrity assurance Instrumentation troubleshooting Vendor selection Laboratory equipment performance testing and validation IT user and group management Procedural guides Operational management Preventive action implementation Laboratory instrument validation Testing and evaluation Equipment installation Software implementation Hardware maintenance Configuration management Equipment troubleshooting Corrective and preventive actions (CAPA) Operating system updates
FDA 21 CFR
Part 11 GMP Software installation Enterprise software support Data integrity and documentation Laboratory equipment repair Hardware support Compliance documentation Data access controls implementation User acceptance testing Vendor relationship management Software documentation Full Job Description 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 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
QUALIFICATIONS
Education:
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
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. Benefits
Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
