Systems Engineer II (GxP)

Role Summary

The Systems Engineer II (GxP) is responsible for ensuring that enterprise infrastructure, identity, cloud, and collaboration platforms operate in a validated, compliant, and audit-ready state throughout their lifecycle. This role partners closely with Computer System Validation (CSV) and Quality Assurance (QA) teams, as well as system owners, to execute validation activities, manage change controls, and sustain compliance with GxP and regulatory requirements. The position provides hands-on technical and compliance support across Infrastructure, Microsoft 365, Identity & Access Management, AWS, Backup, and regulated business applications, while advancing automation to maintain continuous system integrity and Health Authority inspection readiness.

Responsibilities

• Act as primary IT Subject Matter Expert for assigned GxP applications (e.g. Okta, AWS, Druva, Netwrix, BMRAM, ICN, SAS, and Empower), including system administration, configuration, and user access provisioning.
• Maintain GxP systems in a validated and compliant state through lifecycle management including impact assessments for upgrades, patches, and configuration changes.
• Manage IT change controls, including risk assessments, approvals, deviations, root cause analysis, and CAPA execution.
• Maintain accurate, audit-ready documentation aligned with USFDA and other global regulatory requirements and internal SOPs.
• Support periodic access reviews and ensure adherence to role-based access controls.
• Partner with QA, CSV, Business System Owner and IT system owners to support validation activities, audits, and ongoing compliance.
• Coordinate with vendors and SMEs for system implementations, enhancements, issue resolution, and upgrades.
• Maintain traceability across requirements, risk, and testing documentation, and support periodic system reviews and revalidation.

Qualifications

• Required: 4+ years supporting IT systems in a regulated GxP environment.
• Required: Strong knowledge of 21 CFR Part 11, Annex 11, GAMP5, and Computer System Validation lifecycle.
• Required: Experience managing IT change controls, deviations, CAPA, and maintaining audit-ready documentation.
• Required: Ability to provide validation documentation and SME support during internal, external, and regulatory audits.
• Required: Familiarity with platforms such as Okta/Entra ID, AWS, Druva, Netwrix, BMRAM, ICN, SAS, Empower, or similar regulated applications.
• Required: Experience implementing compliance controls (e.g., access reviews, configuration monitoring, evidence collection) to maintain a continuous validated state.
• Required: Experience supporting validation processes with secure, traceable, and audit-ready records.
• Required: Strong attention to detail, documentation discipline, and a proactive risk-based compliance mindset.
• Required: Ability to work independently while collaborating effectively with QA, Security, Infrastructure, Cloud, and application teams.

Education

• Bachelor’s degree in IT, Computer Science, Life Sciences, or related field.