AWS Infrastructure Qualification & Validation Specialist jobs in United States
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Katalyst CRO ยท 1 month ago

AWS Infrastructure Qualification & Validation Specialist

positionUnited States
timeContract
remoteRemote
senioritySenior Level
date5+ years exp

Katalyst CRO is seeking a skilled professional to lead and execute Infrastructure Qualification, Operational Qualification, and Performance Qualification documentation for AWS-hosted environments. This role is critical in ensuring the cloud infrastructure meets regulatory compliance standards through robust validation and documentation practices.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

AWS servicesValidation documentationInfrastructure as CodeGxP complianceAudit processesWritten communication

Required

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

Company

Katalyst CRO

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Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
http://katalysthls.com

H1B Sponsorship

Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)

Funding

Current Stage
Growth Stage

Leadership Team

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John Patil
Recruiter, Pharma/CRO Staffing Division
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Recent News

LinkedIn
Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
Company data provided by crunchbase