Insmed Incorporated · 1 day ago
Senior GxP Systems Engineer
San Diego, CA
Full-time
Onsite
Senior Level
$113K/yr - $144K/yrInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Senior GxP Systems Engineer is responsible for the architecture, operation, and compliance of regulated laboratory and manufacturing IT/OT systems, ensuring validated and inspection-ready environments aligned with FDA regulations.
BiotechnologyMedicalPharmaceutical
Responsibilities
Serve as the primary technical owner for Industrial Control Networks (ICN), ensuring appropriate segmentation, security controls, resilience, and availability for validated and non-validated domains
Lead operational support for infrastructure platforms including VMware virtualization, Veeam backup and disaster recovery, Cisco switching, and firewalls
Manage scientific instrument connectivity, data collection, data storage, backup, retention, and archival processes in accordance with data integrity and regulatory requirements
Ensure ongoing IT readiness for IND-enabling activities, GMP laboratory operations, and future program scale
Provide senior-level ownership for systems operating within GxP- and SOX-controlled environments, ensuring alignment with FDA regulatory expectations and internal quality standards
Ensure compliance with 21 CFR Part 11, data integrity principles (ALCOA+), and GDPR where applicable
Apply and enforce GAMP 5 principles across the system lifecycle, including risk-based validation strategy, periodic review, and system retirement
Lead and review Computer Systems Validation (CSV) deliverables including URS, FRS/FS, DDS/HDS/SDS, IQ/OQ/PQ, and traceability matrices
Serve as a senior IT representative during internal audits, regulatory inspections, and quality reviews, supporting application owners as needed
Drive remediation planning, CAPAs, and continuous improvement initiatives related to regulated systems
Provide senior oversight of Active Directory services including user provisioning, security group governance, and Group Policy administration for regulated and non-regulated domains
Enforce role-based access control, segregation of duties, and least-privilege principles to support compliance and audit readiness
Lead third-party vendor relationships supporting GMP infrastructure and ICN environments, ensuring vendor qualification and inspection readiness
Establish and maintain compliant SOPs, Work Instructions, Policies, and controlled user forms within the Quality Management System (QMS)
Support regulated laboratory applications including LIMS and SDMS as a secondary engineer, providing backup coverage, infrastructure support, and validation assistance in coordination with application owners
Support application owners as a contributing Change Control participant for LIMS, SDMS, and other regulated laboratory systems
Qualification
Required
Minimum of a Bachelor's degree in Information Technology, Computer Science, Engineering, or equivalent experience
Significant experience supporting GxP-regulated laboratory and/or manufacturing environments within an FDA-regulated organization
Advanced expertise in Computer Systems Validation (CSV) and FDA regulations, including 21 CFR Part 11
Strong working knowledge of GAMP 5 and risk-based validation methodologies
Hands-on experience with VMware, Veeam, Cisco networking, and firewalls
Experience supporting ICN environments and collaborating with LIMS, SDMS, and QC laboratory system owners
Preferred
Experience supporting GMP clinical manufacturing environments
Experience working within an enterprise QMS (e.g., Veeva) preferred
Prior involvement in FDA inspections or regulatory submissions
Experience providing secondary or backup support for validated laboratory applications
Benefits
Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
Founded in 1988
1001-5000 employees
H1B Sponsorship
Insmed Incorporated 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 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Drayton Wise
Chief Commercial Officer
Recent News
2026-01-03
Company data provided by crunchbase