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Orevan

Senior SRE Engineer

Orevan, Sunnyvale, California, United States, 94087

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Must have GXP & Pharma clients Experience

Qualifications Bachelor’s or Master’s degree in Computer Science, Engineering, or related field.

9+ years in Production Engineering, DevOps, or SRE roles within healthcare, medical device, or life sciences industries.

Expertise in containerization (Kubernetes, Docker), cloud platforms, and infrastructure-as-code.

Direct experience supporting systems subject to FDA GxP and HITRUST compliance; familiarity with HIPAA, SOC2, ISO 27001 frameworks.

Strong skills in scripting/automation (Python, Bash, Go).

Proven track record managing SIEM and monitoring platforms in regulated environments.

In-depth knowledge of incident response and reliability engineering in healthcare/medical device settings.

Certifications in cloud security, DevOps, and/or healthcare compliance (e.g., HITRUST, AWS Security, etc.) strongly preferred.

Experience deploying and supporting medical device software under FDA regulations.

Familiarity with quality management systems, validation procedures, and documentation for regulatory audits and FDA submissions.

Strong communication and leadership skills for cross-functional collaboration in a regulated setting.

Ability to innovate while maintaining strict compliance constraints.

MUST-HAVES (Non-Negotiable Screening Criteria)

Core SRE / Production Engineering

7+ years in SRE, Production Engineering, or DevOps

Hands-on experience supporting production systems (not just development)

Strong ownership of incident response (on-call, triage, RCA, postmortems)

Monitoring & Observability (KEY FOCUS)

Hands-on experience with monitoring tools, such as Elastic (ELK)

Experience defining and managing SLIs, SLOs, SLAs

Ability to design alerting strategies that balance reliability and compliance

Experience with SIEM / log aggregation tools and support security incidents in production

Regulated Environment Experience (HARD REQUIREMENT)

Direct experience working in regulated healthcare, medical device, or life sciences environments (FDA GxP, HITRUST, HIPAA, SOC2, ISO 27001)

Experience producing audit-ready documentation

Cloud, Containers & Infrastructure

Strong hands-on experience with Cloud platforms: AWS, GCP, or Azure

Terraform, Ansible

Experience embedding compliance controls into IaC and CI/CD pipelines

Automation & Scripting

Strong scripting skills in Python, Bash, Go (preferred but not mandatory)

Automation of deployments, monitoring, and remediation workflows

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