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 IT GxP Systems Engineer serves as a key liaison between IT, Quality Assurance (QA), and system owners to ensure regulated IT systems remain compliant with GxP requirements. This role is responsible for executing impact assessments for system releases, managing IT-related change controls, deviations, and CAPAs, and ensuring all documentation and processes adhere to regulatory standards.

As part of the Support Services department, this engineer takes a broad ownership approach — supporting a range of IT systems, independently managing projects end-to-end, and continuously building expertise across new platforms and technologies as business needs evolve. While GxP compliance remains a core focus, the role is designed for someone who thrives in a dynamic environment, picks up new systems quickly, and proactively contributes beyond a defined scope.

What You'll Do:

Key Responsibilities

Compliance & Governance

•       Ensure GxP systems remain in a validated and compliant state through lifecycle management.

•       Perform release impact assessments for upgrades, patches, and configuration changes.

•       Maintain complete and accurate documentation aligned with regulatory and internal SOPs.

•       Support periodic user access audits and ensure access complies with role-based controls.

 

Change Control & Quality Events

•       Initiate and manage IT change controls, ensuring risk assessments and approvals are completed.

•       Handle deviations and support investigation, root cause analysis, and remediation activities.

•       Draft and implement CAPAs to address compliance gaps or audit findings.

 

IT Systems Ownership & Support

•       Take ownership of assigned GxP and non-GxP IT systems, serving as the primary point of contact for issue resolution, enhancements, and stakeholder communication.

•       Support the broader IT systems portfolio within the Support Services department as needed, including non-primary systems, to ensure continuity and coverage.

•       Independently manage IT projects from initiation through completion, including scoping, coordination, and delivery with minimal supervision.

•       Proactively learn and develop proficiency in new systems and technologies as the department's needs expand.

•       Coordinate with vendors and internal subject matter experts for system upgrades, issue resolution, and enhancements.

•       Partner with QA, CSV, and IT system owners on validation activities and ongoing compliance needs.

•       Support internal and external audits by providing system documentation and evidence.

 

Documentation & Processes

•       Maintain traceability across requirements, risk assessments, and test documentation.

•       Ensure SOPs, work instructions, and system records are kept current and accurate.

•       Support periodic system reviews and revalidation efforts.

 

Qualifications

Required

•       Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field.

•       3+ years of experience in IT systems support within a regulated (GxP/FDA/EU) environment.

•       Strong understanding of 21 CFR Part 11, Annex 11, and computer system validation principles.

•       Experience managing IT change controls, deviations, CAPAs, and quality documentation.

•       Demonstrated ability to independently manage projects and take ownership of systems and processes.

•       Ability to learn and support a variety of IT systems across different functional areas.

 

Preferred

•       Familiarity with regulated IT applications commonly used in life sciences or laboratory environments.

•       Knowledge of ITIL or service management workflows for change and incident management (e.g., ServiceNow).

•       Prior audit support experience (internal or regulatory).

•       Experience supporting systems across multiple domains (e.g., identity management, document control, laboratory, financial, or operational systems).

 

Key Competencies

•       Detail-oriented with strong documentation and organizational skills.

•       Proactive ownership mindset — identifies gaps and drives resolution without waiting to be directed.

•       Adaptable and curious; able to quickly learn and support unfamiliar systems and tools.

•       Ability to work independently while collaborating effectively with cross-functional teams.

•       Strong problem-solving and analytical skills.

•       Excellent communication skills across technical and non-technical stakeholders.

Who You Are:

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 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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

 

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.