Job Description

: Technical Skills
1. AWS Services Proficiency
o Deep understanding of core AWS services like EC2, S3, RDS, IAM, VPC, CloudWatch, CloudTrail, Lambda, etc.

• Experience with AWS CloudFormation or Terraform for Infrastructure as Code (IaC)

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2. Infrastructure as Code (IaC)
o Ability to define, deploy, and manage infrastructure using tools like:
? AWS CloudFormation

• Terraform
• AWS CDK
• Ansible, Chef, Puppet

3. Automation & CI/CD
o Familiarity with CI/CD pipelines using tools like Jenkins, GitHub Actions, AWS CodePipeline.

• Use of automated testing frameworks like Chef InSpec for validation

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4. Monitoring & Logging
o Experience with AWS CloudWatch, CloudTrail, and third-party tools for infrastructure monitoring and audit trails.
5. Security & Compliance
o Knowledge of AWS security best practices including IAM policies, encryption (KMS), and network security.

• Understanding of GxP, HIPAA, or other regulatory frameworks relevant to the workload

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Documentation & Validation Skills
1. Computer System Validation (CSV) Knowledge
o Familiarity with GAMP 5 guidelines and SDLC documentation practices.

• Ability to write Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents

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2. Documentation Tools
o Experience with tools like Confluence, SharePoint, or custom documentation platforms.

• Ability to generate architecture diagrams using AWS icon sets or modeling tools like Lucidchart, Draw.io, or C4/UML models

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3. Audit & Traceability
o Skills in maintaining version-controlled documentation and traceability matrices.

• Understanding of audit requirements and how to prepare documentation for regulatory inspections.

? Soft Skills
? Attention to Detail: Critical for validation and compliance documentation.
? Analytical Thinking: To assess infrastructure risks and validation gaps.
? Communication Skills: To collaborate with cross-functional teams including QA, DevOps, and regulatory affairs

Skills Required