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AWS Infrastructure Qualification & Validation Specialist

• Posted 60+ days ago • Updated 6 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

JD
Pharmaceutics
IQ
OQ
PQ
Collaboration
DevOps
Cloud Computing
Computerized System Validation
Management
Traceability Matrix
Risk Assessment
Microsoft SharePoint
Confluence
Progress Chef
Computer Science
Information Systems
IaaS
Amazon Web Services
Amazon EC2
Amazon S3
Remote Desktop Services
Amazon RDS
Virtual Private Cloud
Terraform
GxP
GAMP
HIPAA
ISO/IEC 27001:2005
Regulatory Compliance
Communication
Documentation
Auditing

Summary

Job Description (JD):

For a role focused on Infrastructure Qualification and Validation Documentation for AWS-tailored for regulated environments like pharma, biotech, or any GxP-compliant organization.
We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices.

Responsibilities:

Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components.
Collaborate with DevOps and Cloud Engineering teams to understand architecture and deployment models.
Ensure infrastructure is validated according to GAMP 5 and Computer System Validation (CSV) principles.
Create and manage traceability matrices, risk assessments, and validation plans.
Support internal and external audits by providing documentation and evidence of compliance.
Maintain version-controlled documentation repositories (e.g., SharePoint, Confluence).
Define and implement automated validation checks using tools like Chef InSpec or AWS Config.
Stay updated with AWS service changes and assess their impact on validated environments.

Requirements:

Bachelor's degree in computer science, Information Systems, or related field.
5+ years of experience in cloud infrastructure, preferably AWS.
3+ years in validation or compliance documentation in regulated industries.
Strong understanding of AWS services: EC2, S3, RDS, IAM, VPC, CloudTrail, CloudWatch.
Experience with Infrastructure as Code (IaC) tools: Terraform, CloudFormation.
Familiarity with GxP, GAMP 5, HIPAA, or ISO 27001 compliance frameworks.
Excellent written communication and documentation skills.
Experience with audit processes and regulatory inspections.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 3a665ca6116e7aa0012034384fc93fcb
Posted 30+ days ago

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