Description

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 Senior GxP Systems Engineer 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 Senior GxP 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'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.
• 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.

Who You Are:

You have a minimum of a Bachelor's degree in Information Technology, Computer Science, Engineering, or equivalent experience.

You are or you have:

• 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 Qualifications:

• 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.

Location: Supporting three sites in San Diego

#LI-EG1

#onsite

Pay Range:
$113,000.00-143,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.