Demo

Senior AWS Cloud Architect - GxP Compliance Specialist

NCS Technologies
Boston, MA Full Time
POSTED ON 4/9/2025
AVAILABLE BEFORE 5/2/2025

We need a solid AWS Cloud expert who has extensive experience and knowledge of Pharma GxP compliance requirements to assist with the installation of an AWS Cloud VPC. Oversee the implementation a VPC dedicated to GxP compatibility and its components.

Responsibilities

  • Design and implement a validated AWS infrastructure adhering to GxP requirements, including VPC architecture, security controls, and compliance monitoring
  • Develop and execute Infrastructure as Code (IaC) using AWS CloudFormation / Terraform with validation controls
  • Create and maintain Computer System Validation (CSV) documentation including validation master plans, requirements, specifications, and test protocols
  • Establish in AWS the necessary components for Access Controls, Data Security, Network Security & Data Integrity
  • Design and validate backup / recovery procedures meeting GxP requirements
  • Establish validated CI / CD pipelines that maintain GxP compliance
  • Lead infrastructure qualification activities (IQ / OQ / PQ) for AWS components
  • Create and maintain SOPs for cloud infrastructure management
  • Interface with Quality Assurance teams for compliance reviews

Required Qualifications :

  • 8 years of AWS cloud architecture experience
  • 5 years of experience with GxP compliance in pharmaceutical industry
  • AWS Professional level certifications (Solutions Architect and / or DevOps)
  • Deep understanding of 21 CFR Part 11, EU Annex 11, and GAMP 5
  • Experience with infrastructure validation in regulated environments
  • Strong knowledge of AWS security services and compliance features
  • Expertise in AWS services : VPC, EC2, S3, RDS, IAM, CloudTrail, Config, Shield, WAF, Macie, KMS
  • Experience with infrastructure automation tools (Terraform / CloudFormation)
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