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) [1] .
2.

Infrastructure as Code (IaC)

o Ability to define, deploy, and manage infrastructure using tools like:


AWS CloudFormation


Terraform AWS CDK Ansible, Chef, Puppet [1]
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 [1] .
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 [2] .


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 [2] .
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 [3] .
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