Senior GxP Systems Engineer – San Diego

Requirements

• Bachelors degree in Information Technology, Computer Science, Engineering, or related field
• Significant experience in supporting GxP-regulated laboratory and/or manufacturing environments within an FDA-regulated organization
• Advanced knowledge of Computer Systems Validation (CSV) and FDA regulations, including 21 CFR Part 11
• Strong understanding of GAMP 5 and risk-based validation methodologies
• Hands-on familiarity with VMware, Veeam, Cisco networking, and firewalls
• Experience supporting Industrial Control Networks (ICN) and collaborating with LIMS, SDMS, and QC laboratory system owners

Responsibilities:

• Act as the primary technical owner for Industrial Control Networks (ICN), ensuring proper segmentation, security controls, resilience, and availability
• Lead operational support for infrastructure platforms including VMware, Veeam, Cisco switching, and firewalls
• Manage connectivity for scientific instruments, ensuring data collection, storage, backup, and archival align with data integrity and regulatory standards
• Ensure IT readiness for IND-enabling activities and GMP laboratory operations
• Oversee systems in GxP- and SOX-controlled environments, ensuring compliance with FDA regulations and internal quality standards
• Ensure adherence to 21 CFR Part 11, data integrity principles (ALCOA+), and GDPR regulations where applicable
• Apply and enforce GAMP 5 principles throughout the system lifecycle, including validation strategies
• Lead and review Computer Systems Validation (CSV) deliverables including URS, FRS/FS, and traceability matrices
• Act as a senior IT representative during audits, inspections, and quality reviews, providing support as needed
• Facilitate remediation planning, CAPAs, and continuous improvement initiatives related to regulated systems
• Provide oversight of Active Directory services, including user provisioning and security governance
• Implement role-based access control and segregation of duties to maintain compliance
• Manage third-party vendor relationships for GMP infrastructure and ICN environments
• Establish and maintain compliant SOPs, Work Instructions, Policies, and controlled user forms
• Support regulated laboratory applications such as LIMS and SDMS in a secondary engineer capacity

Company:

At Insmed, we are dedicated to transforming the lives of patients with serious and rare diseases. Our culture prioritizes the human experience, values curiosity, and recognizes each individuals contributions to meaningful progress. We are proud to be recognized as the top employer by Science magazine for five consecutive years, certified as a Great Place to Work® in the U.S., and included in The Sunday Times Best Places to Work list in the UK.

This role is based in San Diego and offers a competitive pay range along with comprehensive benefits such as medical, dental, and vision coverage, generous paid time off policies, a strong 401(k) plan, and access to professional development opportunities.