CSV Validation Analyst

Zifo; México; Presencial; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Christmas bonus

Descripción de la vacante

Zifo Mexico is seeking an IT professional to support Laboratory and Manufacturing operations in GMP and non-GMP environments. You will collaborate with cross-functional teams to drive day-to-day IT services and project-based initiatives.

The role emphasizes troubleshooting hardware and software, performing computer system validation (IQ/OQ/PQ), ensuring data integrity and regulatory compliance, and managing access control and security patches in validated production settings.

Formación

• Bachelor’s degree with 3+ years in lab IT or biotech/pharma.
• Master’s with 3–5+ years in related field.
• Strong knowledge of Windows OS administration and network basics.
• Experience with validated systems in regulated GxP environment.

Responsabilidades

• Support lab equipment and applications (GMP and non-GMP).
• Troubleshoot hardware and software issues.
• Perform computer system validation activities (IQ/OQ/PQ).
• Maintain data integrity and regulatory compliance for GMP systems.
• Administer system configuration, access management, and security patching.
• Provide input for Investigations, Change Controls, CAPAs, and audits.
• Lead or support periodic reviews and user access reviews.
• Execute UAT with IT and business teams.
• Provide hands-on support for QC and Manufacturing instrument systems.

Conocimientos

Lab IT expertise

Windows administration

Network fundamentals

Regulatory compliance awareness

GxP experience

Educación

Bachelor's in IT/CS/Life Sciences

Master's with relevant experience

Descripción del empleo

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 ideal 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 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 3+ 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).
• 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.
  

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. 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 superior benefits to those outlined by law, a competitive compensation package including accrued vacation, and a healthy Christmas bonus.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo Mexico 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.