Katalyst Healthcares and Life Sciences
AWS Infrastructure Qualification & Validation Specialist
Katalyst Healthcares and Life Sciences, San Francisco, California, United States, 94199
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.
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.