Systems Engineer II (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 Systems Engineer II (GxP) is responsible for ensuring that enterprise infrastructure, identity, cloud, and collaboration platforms operate in a validated, compliant, and audit-ready state throughout their lifecycle. This role partners closely with Computer System Validation (CSV) and Quality Assurance (QA) teams, as well as system owners, to execute validation activities, manage change controls, and sustain compliance with GxP and regulatory requirements. The position provides hands-on technical and compliance support across Infrastructure, Microsoft 365, Identity & Access Management, AWS, Backup, and regulated business applications, while advancing automation maintain continuous system integrity and Health Authority inspection readiness.

What You'll Do:

In this role, you will ensure GxP-relevant Infrastructure and enterprise systems such as , Identity, Microsoft 365, and AWS cloud platforms remain in a validated, compliant, and audit-ready state throughout their lifecycle. You will lead validation and compliance activities for enterprise systems, including change management, incident management, lifecycle governance, and implementation controls that sustain a continuous validated state.

You'll also:

• Act as primary IT Subject Matter Expert for assigned GxP applications (e.g. Okta, AWS, Druva, Netwrix, BMRAM, ICN, SAS, and Empower), including system administration, configuration, and user access provisioning.
• Maintain GxP systems in a validated and compliant state through lifecycle management including impact assessments for upgrades, patches, and configuration changes.
• Manage IT change controls, including risk assessments, approvals, deviations, root cause analysis, and CAPA execution.
• Maintain accurate, audit-ready documentation aligned with USFDA and other global regulatory requirements and internal SOPs.
• Support periodic access reviews and ensure adherence to role-based access controls.
• Partner with QA, CSV, Business System Owner and IT system owners to support validation activities, audits, and ongoing compliance.
• Coordinate with vendors and SMEs for system implementations, enhancements, issue resolution, and upgrades.
• Maintain traceability across requirements, risk, and testing documentation, and support periodic system reviews and revalidation.

Who You Are:

You are or you have:

• Bachelor's degree in IT, Computer Science, Life Sciences, or related field.
• 4+ years supporting IT systems in a regulated GxP environment.
• Strong knowledge of 21 CFR Part 11, Annex 11, GAMP5, and Computer System Validation lifecycle.
• Experience managing IT change controls, deviations, CAPA, and maintaining audit-ready documentation.
• Ability to provide validation documentation and SME support during internal, external, and regulatory audits.
• Familiarity with platforms such as Okta/Entra ID, AWS, Druva, Netwrix, BMRAM, ICN, SAS, Empower, or similar regulated applications.
• Experience implementing compliance controls (e.g., access reviews, configuration monitoring, evidence collection) to maintain a continuous validated state.
• Experience supporting validation processes with secure, traceable, and audit-ready records.
• Strong attention to detail, documentation discipline, and a proactive risk-based compliance mindset.
• Ability to work independently while collaborating effectively with QA, Security, Infrastructure, Cloud, and application teams.

Preferred Qualifications:

• Hands-on experience supporting and maintaining validated Infrastructure, M365, IAM, Cloud, and laboratory/manufacturing platforms within regulated environments.
• Knowledge of ITIL practices and ServiceNow workflows for change and incident management.
• Prior participation in internal audits and/or regulatory inspections.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [email protected] 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.