IAM Technical Validation Specialist (GxP / CSV) - Pharma

We are looking for a hands-on IAM Technical Validation Specialist who treats compliance as code and process automation. You will play a critical support and co-leadership role in scaling our enterprise Identity & Access Management (IAM) infrastructure within a strictly regulated GxP environment.

Unlike traditional paper-based validation roles, this position requires deep technical fluency in IT infrastructure, access management architecture, service management frameworks, and computerized system validation (CSV / CSA).

Key Responsibilities:

• IT Systems & Infrastructure Validation Strategy: Define and execute the technical validation strategy, scope, and lifecycle controls for enterprise identity platforms, hybrid identity connectors, and integration workflows.
• Technical Infrastructure & Access Oversight: Review and validate complex technical configurations, including Active Directory, Azure/Microsoft Entra ID, SailPoint architecture, API integrations, single sign-on (SSO), and role-based access control (RBAC / SoD) frameworks.
• ITIL & Change Management Integration: Ensure all changes, patches, system updates, releases, and infrastructure incidents are rigorously assessed using ITIL service management principles and GxP change control workflows.
• Technical Risk & Test Management: Design and review risk-based technical test protocols (IQ/OQ/PQ), traceability matrices, automated testing evidence, and integration performance scripts using modern CSA methodologies.
• Deviations & CAPA Engineering: Investigate and manage technical system deviations, root-cause analysis (RCA), and corrective/preventive actions (CAPAs) related to identity provisioning, synchronization failures, or platform outages.
• Cross-Functional Collaboration: Act as the technical bridge between IT Infrastructure, Cybersecurity, Quality Assurance, business owners, and external technology providers to address risks and implement sustainable solutions.
• Lifecycle Management: Maintain the platform in a validated state through change and incident management, periodic reviews, supplier oversight, backup and recovery, archiving, and system retirement.
• Audit Readiness: Represent IAM Validation during audits, self-inspections, regulatory inspections, and management reviews.
• Innovation & Continuous Improvement:Identify compliance gaps and opportunities to simplify or automate validation and assurance activities.

Skills & Requirements:

• Education:Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related field, or equivalent professional experience.
• Experience:3+ years of experience working in a regulated GxP environment.
• CSV & Regulatory Knowledge: Solid expertise in Computerized System Validation (CSV), Computer Software Assurance (CSA), GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11.
• IAM & Technical Fluency: Hands-on understanding of identity directories (Active Directory, LDAP), access control mechanisms, user provisioning lifecycles, and identity governance platforms (SailPoint, Microsoft Entra ID or similar).
• Documentation & Testing:Demonstrated experience with validation documentation, risk assessments, traceability, testing, objective evidence, and validation reports.
• Communication Skills: Strong analytical mindset with the ability to translate complex IT and security architecture into structured validation controls. Fluent English (written and spoken).

Conditions & Benefits

• Work-Life Integration: Hybrid model (4 days remote, 1 collaborative day on-site every Thursday) with flexible working hours.
• Perks & Flexibility: Flexible compensation plan (customizable health insurance, transit, childcare) + daily meal vouchers for on-site days.
• Growth: Opportunity to shape enterprise-scale IAM architecture and drive modernization/automation initiatives in a global pharma setting.