Lead IT Systems Engineer (GxP)
Insmed Incorporated
1 month ago
On-site
San Diego, CA
$133,000 - $173,000 USD yearly
IT
Responsibilities
- Lead architecture, operation, and compliance for regulated laboratory/manufacturing IT/OT systems across multiple sites; primary owner of GMP infrastructure environments.
- Provide lifecycle support for VMware, Veeam backup/DR, Cisco switching, and firewalls.
- Own Industrial Control Networks (ICN): segmentation, security controls, resilience, and availability.
- Manage instrument connectivity and data processes (collection, storage, backup, retention, archival) per data integrity/regulations.
- Ensure readiness for IND-enabling/GMP operations; support GxP and SOX-controlled systems.
- Ensure compliance with 21 CFR Part 11, ALCOA+ principles, and GDPR (as applicable); apply GAMP 5; lead/review CSV deliverables (URS, FRS/FS, DDS/HDS/SDS, IQ/OQ/PQ, traceability).
- Represent IT during audits/inspections; drive CAPAs/remediation/continuous improvement.
- Oversee Active Directory (provisioning, security groups, Group Policy); enforce RBAC, segregation of duties, least privilege.
- Lead third-party vendor relationships for GMP/ICN; manage vendor qualification and inspection readiness.
- Maintain compliant SOPs/Work Instructions/policies/forms in QMS; support LIMS/SDMS as secondary engineer; participate in change control.
Qualifications & Required Skills
- Bachelor’s degree in IT/CS/Engineering or equivalent.
- 7+ years hands-on VMware, Veeam, Cisco networking, and firewalls.
- Significant GxP-regulated lab/manufacturing experience in an FDA-regulated organization.
- Advanced CSV and FDA regulations expertise (including 21 CFR Part 11).
- Strong GAMP 5 and risk-based validation knowledge.
- ICN experience; collaboration with LIMS/SDMS/QC owners.
Nice to Have
- GMP clinical manufacturing; enterprise QMS (e.g., Veeva); backup/secondary support for validated lab applications.
Work/Travel
- San Diego, CA; full-time in-person. Minimal travel.
Pay/Benefits
- $133,000–$173,000 annual. Medical/dental/vision, mental health/EAP, PTO, caregiver/family-forming support, 401(k) match, equity/ESPP, life/disability insurance, learning programs.
Application
- Current employees: apply via Jobs Hub in Workday. Applications accepted for 5 calendar days from posting date or until filled.
- Lead architecture, operation, and compliance for regulated laboratory/manufacturing IT/OT systems across multiple sites; primary owner of GMP infrastructure environments.
- Provide lifecycle support for VMware, Veeam backup/DR, Cisco switching, and firewalls.
- Own Industrial Control Networks (ICN): segmentation, security controls, resilience, and availability.
- Manage instrument connectivity and data processes (collection, storage, backup, retention, archival) per data integrity/regulations.
- Ensure readiness for IND-enabling/GMP operations; support GxP and SOX-controlled systems.
- Ensure compliance with 21 CFR Part 11, ALCOA+ principles, and GDPR (as applicable); apply GAMP 5; lead/review CSV deliverables (URS, FRS/FS, DDS/HDS/SDS, IQ/OQ/PQ, traceability).
- Represent IT during audits/inspections; drive CAPAs/remediation/continuous improvement.
- Oversee Active Directory (provisioning, security groups, Group Policy); enforce RBAC, segregation of duties, least privilege.
- Lead third-party vendor relationships for GMP/ICN; manage vendor qualification and inspection readiness.
- Maintain compliant SOPs/Work Instructions/policies/forms in QMS; support LIMS/SDMS as secondary engineer; participate in change control.
Qualifications & Required Skills
- Bachelor’s degree in IT/CS/Engineering or equivalent.
- 7+ years hands-on VMware, Veeam, Cisco networking, and firewalls.
- Significant GxP-regulated lab/manufacturing experience in an FDA-regulated organization.
- Advanced CSV and FDA regulations expertise (including 21 CFR Part 11).
- Strong GAMP 5 and risk-based validation knowledge.
- ICN experience; collaboration with LIMS/SDMS/QC owners.
Nice to Have
- GMP clinical manufacturing; enterprise QMS (e.g., Veeva); backup/secondary support for validated lab applications.
Work/Travel
- San Diego, CA; full-time in-person. Minimal travel.
Pay/Benefits
- $133,000–$173,000 annual. Medical/dental/vision, mental health/EAP, PTO, caregiver/family-forming support, 401(k) match, equity/ESPP, life/disability insurance, learning programs.
Application
- Current employees: apply via Jobs Hub in Workday. Applications accepted for 5 calendar days from posting date or until filled.