Computerized System Validation Specialist (Pharma/Cro)

Cohortias - The Cro Of Latin America; Xico; Híbrido; MXN 850.000 - 1.100.000; Jornada completa

Descripción de la vacante

Cohortias is seeking a Computerized System Validation Specialist (CSVS) to establish, implement, and maintain governance, compliance, and validation frameworks across our IT landscape in Mexico City. The role is specialist-level and autonomous, focusing on GxP-regulated and eClinical systems with strong technical rigor.

You will own validation lifecycle activities end-to-end, drive risk-based testing, and support sponsor audits and regulatory inspections, ensuring data integrity and compliance

Formación

• 5–7 years QA or CSV experience in Pharma/Biotech/Medical Device or CRO sectors.
• 3+ years authoring CSV protocols and leading GxP assessments.
• Bachelor’s degree in Life Sciences, Pharmacy, CS or related field.
• Advanced English for global stakeholder interactions.

Responsabilidades

• Define, implement, and maintain SOPs and validation strategies across systems.
• Plan, author, and execute risk-based validation deliverables (IQ/OQ/PQ) and CSA protocols.
• Perform regulatory and quality risk management per ICH Q9, 21 CFR Part 11, EU Annex 11.
• Oversee vendor qualification, SLAs, audit trails, and change controls.
• Coordinate RCA, deviations, CAPAs, and BCP/DR for critical tech platforms.
• Serve as SME during sponsor audits and regulatory inspections.

Conocimientos

Execution & Ownership Mindset

Quality Assurance

CSV Experience

Educación

Bachelor's degree in Life Sciences

Descripción del empleo

We are hiring a Computerized System Validation Specialist (Pharma/CRO)

At Cohortias , we are looking for a highly skilled, autonomous, and hands-on Computerized System Validation Specialist (CSVS) to establish, implement, and maintain our technology governance, compliance, and validation framework.

This is a specialist-level individual contributor role designed for a technical professional who excels at both structuring compliance strategies and directly executing validation lifecycle activities. You will take direct ownership of the compliance state across our entire organizational software and IT ecosystem , ensuring seamless operations while maintaining rigorous quality standards.

Location: Mexico City (Hybrid Model)

About the Role & Scope:

As our CSVS, you will oversee the compliance, security, and validation lifecycle for all internal and external technology solutions. While managing the broader IT technology landscape, you will place special emphasis on GxP-regulated and eClinical systems , ensuring they strictly adhere to international regulatory frameworks, including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH E6(R3), ICH Q9, and applicable Data Privacy laws (GDPR / Local Regulations) .

Working in a lean and dynamic CRO environment, you will drive validation initiatives end-to-end with high autonomy, agility, and technical rigor.

Key Responsibilities:

• Technology Governance & Policy: Define, implement, and maintain SOPs, Work Instructions, and validation strategies for all computerized systems across their lifecycle.
• System Validation & Testing: Plan, author, and execute risk-based validation deliverables, test scripts (IQ/OQ/PQ), and Computerized System Assurance (CSA) protocols for corporate software, cloud infrastructure, and eClinical platforms.
• Regulatory & Quality Risk Management: Conduct compliance gap analyses and quality risk assessments (ICH Q9) to ensure full alignment with 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity (ALCOA++) principles .
• Vendor Qualification & Oversight: Oversee technology service providers, SaaS vendors, and IT infrastructure partners by managing Quality Agreements, SLAs, audit trails, and change controls.
• Incidents & Business Continuity: Coordinate root cause analyses (RCA), deviations, CAPA plans, and business continuity/disaster recovery (BCP/DR) protocols for critical technology platforms.
• Audit Readiness: Act as the Subject Matter Expert (SME) for computerized systems and data integrity during sponsor audits and regulatory inspections.

What We Are Looking For:

• Industry Experience (Strict Requirement): 5–7 years of Quality Assurance or CSV experience strictly within the Pharmaceutical, Biotech, Medical Device, or CRO industries .
• Execution & Ownership Mindset: Proven track record in mid-sized or CRO environments, with the agility and capability to design compliance frameworks and personally execute validation deliverables.
• Specialization: At least 3 years of direct experience authoring CSV protocols, leading GxP compliance assessments, and conducting IT vendor evaluations.
• Education: Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, Software Engineering, or related scientific/technical fields.
• Technical Knowledge: Deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA++, ICH guidelines, and eClinical architectures (EDC, eTMF, CTMS, RTSM/IWRS).
• Languages: Advanced English (fluent written and spoken) for global stakeholder and audit interactions.