Lead IT Systems Engineer (GxP)

Insmed Incorporated • San Diego, CA

29d • Onsite

About The Position

The Lead IT Systems Engineer (GxP) is a senior technical role responsible for the architecture, operation, and compliance of regulated laboratory and manufacturing IT/OT systems across multiple operational sites. This position provides primary ownership of GMP infrastructure environments and serves as a supporting and backup engineer for regulated laboratory applications including LIMS and SDMS, which are owned by designated application engineers. The role focuses on sustaining and scaling existing GMP laboratory and clinical manufacturing sites, addressing operational and compliance risks associated with system redundancy, availability, and regulatory scope. The Lead Systems Engineer operates with a high degree of autonomy and partners closely with Quality, Manufacturing, Laboratory, and IT stakeholders to ensure validated, compliant, and inspection-ready environments aligned with FDA regulations and GAMP 5 principles.

Requirements

• You have a minimum of a Bachelor’s degree in Information Technology, Computer Science, Engineering, or equivalent experience.
• At least 7 years of hands-on experience with VMware, Veeam, Cisco networking, and firewalls.
• 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.
• Experience supporting ICN environments and collaborating with LIMS, SDMS, and QC laboratory system owners.

Nice To Haves

• 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.

Responsibilities

• Provide senior-level support and lifecycle management for GMP-compliant IT and OT infrastructure across existing laboratory and clinical manufacturing sites.
• Lead operational support for infrastructure platforms including VMware virtualization, Veeam backup and disaster recovery, Cisco switching, and firewalls.
• 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.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level