Desired Skills and Certifications
1. AWS Expertise
- Certifications: AWS Certified Solutions Architect (Associate/Professional), AWS Certified DevOps Engineer, or AWS Certified SysOps Administrator are often preferred.
- Cloud Operations: Experience with cloud infrastructure management, automation, monitoring, and scaling in an AWS environment.
- Security & Compliance Tools: Proficiency with AWS services like IAM (Identity and Access Management), AWS CloudTrail, AWS Config, and AWS GuardDuty.
- Automation: Experience with Infrastructure as Code (IaC) tools like AWS CloudFormation, Terraform, and CI/CD pipelines.
2. GxP Compliance Knowledge
- GxP Frameworks: Understanding of GxP requirements, particularly as they pertain to cloud services used in regulated industries (e.g., pharma, biotech, medical devices).
- Validation Processes: Familiarity with qualification and validation processes (IQ/OQ/PQ) for systems in regulated environments.
- Data Integrity: Knowledge of data integrity principles (e.g., ALCOA – Attributable, Legible, Contemporaneous, Original, Accurate) and ensuring compliance with regulatory guidelines.
- Audit Trails and Documentation: Experience with generating and maintaining compliant documentation and audit trails for cloud infrastructure.
3. Operational Focus
- Monitoring & Incident Management: Hands-on experience with AWS monitoring services (e.g., CloudWatch, AWS Systems Manager) and incident response in a production environment.
- Disaster Recovery: Ability to design and implement disaster recovery (DR) strategies, including backup and recovery solutions on AWS.
- Performance Optimization: Experience in optimizing performance for cost, scaling, and efficient resource usage.
- 24/7 Availability: Experience with maintaining high-availability architectures in a regulated environment.
4. Security & Risk Management
- Security Best Practices: Deep knowledge of security best practices in AWS, including network segmentation, encryption (KMS), and security group configurations.
- Risk Assessments: Ability to conduct and manage risk assessments in GxP-compliant AWS environments.
- Access Control: Implementation of robust access control policies that meet regulatory requirements.
5. Collaboration & Communication Skills
- Cross-functional Collaboration: Ability to work closely with regulatory, quality, and IT teams to align AWS operations with GxP requirements.
- Documentation: Strong skills in creating SOPs (Standard Operating Procedures), validation protocols, and compliance documentation for AWS systems.
6. Experience with GxP-regulated Industries
- Experience in industries like pharmaceuticals, biotechnology, or healthcare where GxP regulations are critical.
Job Types: Part-time, Contract
Pay: $75.00 per hour
Application Question(s):
- Do you understand this is a part-time position?
Experience:
- Cloud Engineering: 5 years (Required)
- GxP: 5 years (Required)
- DevOps: 5 years (Required)
Work Location: Remote
