CSV Validation Analyst

About the Role

This role supports day-to-day operations and project-based initiatives within cross-functional teams, including colleagues, consultants, vendors, and MSPs. The primary focus is managing daily operational activities and providing Tier 1 and Tier 2 IT Helpdesk support for end users and customers. A hybrid schedule is acceptable, with a preference for 3-4 days onsite weekly.

Key Responsibilities

• Manage daily operational activities and provide Tier 1 and Tier 2 IT Helpdesk support.
• Support lab equipment and applications (GMP and non-GMP).
• Troubleshoot hardware and software issues.
• Perform computer system validation activities, including change controls, validation execution, NCRs, AIRs, and CAPAs.
• Maintain data integrity and compliance.
• Administer system configuration, access management, security patching, and data backup processes.
• Execute and comply with SDLC, Change, Access, Inventory, & operational management procedures for business-critical applications & platforms.
• Support the evaluation, pilot testing, selection, & ongoing management of IT vendors & partners.
• Lead or support the 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.
• Undertake other duties as assigned.

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 a broad range of lab instrumentation and Enterprise IT solutions used in Biopharma (e.g., LC systems, AKTA, SoftMaxPro, Geneious, ELN/LIMS, Imaging Systems, Bioreactors, Plate readers, Sequencers, etc.).

About Zifo

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. 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.

Benefits

• Competitive compensation package.
• Accrued vacation.
• Medical, dental, vision insurance.
• 401k with company matching.
• Life insurance.
• Flexible spending accounts.

Equal Opportunity Employer

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.