Associate Engagement Manager (GxP Validation Expert)

Job Summary


Role Responsibilities

• Infrastructure Qualification: Leading IQ, OQ, and PQ for cloud platforms (AWS, Azure, GCP), virtualized environments, network components, and storage/backup systems.
• Validation Deliverables: Developing and reviewing key validation documents (Validation Plan, URS, FS/DS/CS, Risk Assessments, Traceability Matrix, Validation Summary Report) using a GAMP 5 risk-based approach.
• Hands-on Execution: Performing protocol execution with meticulous evidence capture (logs, screenshots, system outputs).
• Cloud Validation Strategy: Defining validation strategies for GxP-compliant cloud environments (IaaS, PaaS, SaaS) and qualifying cloud services (IAM, logging, encryption, backup/DR).
• Regulatory Compliance: Ensuring alignment with FDA (21 CFR Part 11) and EMA (EU Annex 11) regulations, applying ALCOA+ principles, audit trail requirements, and electronic records/e-signature controls.
• CSA GAMP 5: Applying risk-based validation per GAMP 5, including system categorization and GxP impact assessment, and driving Computer Software Assurance (CSA) adoption.
• Lifecycle Support: Supporting the validation lifecycle through periodic reviews, requalification, and change control impact assessments.
• Collaboration: Partnering with IT and DevOps teams for infrastructure changes, patch management, and configuration drift validation.

Primary Requirements

• Experience: 5+ years in GxP CSV/Validation, with 3+ years specifically in hands-on Infrastructure Qualification.
• Technical Expertise: Proven hands-on experience in Cloud Qualification (AWS/Azure/GCP), Virtualization (VMware/Hyper-V), and Networking validation.
• Industry Background: Experience in regulated industries (Life Science, Healthcare, Medical Devices).
• Security Compliance: Proficiency in IAM, RBAC, Encryption mechanisms, and SIEM/logging tools.
• Tools Documentation: Familiarity with Validation tools (e.g., HP ALM, Azure DevOps, Jira) and creating essential Documentation (SOPs, Validation Plans, RTM).

Secondary Requirements (Good to Have)

• Experience with specific GxP application systems (e.g., LIMS, QMS, MES, Veeva Vault).
• Experience with Infrastructure as Code (IaC) tools (Terraform, CloudFormation).
• Knowledge of DevOps / CI-CD validation practices.
• Knowledge of AI/ML system validation.
• Experience with automated testing tools.
• Ability to design validation strategies and troubleshoot qualification issues.

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