Lead IT Systems Engineer (GxP)

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: 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. What You'll Do: In this role, you’ll have the opportunity to provide senior-level support and lifecycle management for GMP-compliant IT and OT infrastructure across existing laboratory and clinical manufacturing sites. You will lead operational support for infrastructure platforms including VMware virtualization, Veeam backup and disaster recovery, Cisco switching, and firewalls. You’ll also: 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 sec ... (truncated, view full listing at source)