Katalyst CRO
Qualification & Validation Specialist
Katalyst CRO, Redwood City, California, United States, 94061
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Qualification & Validation Specialist
role at
Katalyst CRO
2 days ago Be among the first 25 applicants
Job Summary
Lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments.
Ensure cloud infrastructure meets regulatory compliance standards (GxP, HIPAA, ISO 27001) through robust validation and documentation practices.
Roles & 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.
Education & Experience
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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
San Jose, CA $78,200.00-$116,600.00 14 hours ago
#J-18808-Ljbffr
Qualification & Validation Specialist
role at
Katalyst CRO
2 days ago Be among the first 25 applicants
Job Summary
Lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments.
Ensure cloud infrastructure meets regulatory compliance standards (GxP, HIPAA, ISO 27001) through robust validation and documentation practices.
Roles & 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.
Education & Experience
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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
San Jose, CA $78,200.00-$116,600.00 14 hours ago
#J-18808-Ljbffr