CSV Specialist

Insmed Incorporated

2d • Hybrid

About The Position

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 CSV Specialist will engage on CSV Projects as a key team member. You will provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements. The CSV Specialist will also ensure compliance and operational efficiency of validated systems through participating in release management, change control, periodic reviews, and audit trail reviews. You will support IT Change Control Process. What You'll Do: In this role, you’ll have the opportunity to Provide strategic leadership and decision making on CSV strategy using Insmed’s risk-based approach. You’ll also:

Requirements

• You have minimum of a Bachelor’s degree along with 3+ years’ experience in a validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, Chromeleon, environmental monitoring systems, and other Lab systems.
• Experience in lab equipment and lab business processes.
• Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.
• Strong technical writing skills for authoring, reviewing and approving validation plans, requirements, testing documents and summary reports.
• Experience with Veeva QualityDocs /QMS.
• Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.
• Basic understanding of data integrity (ALCOA+) principles.

Nice To Haves

• Experience with GxP AI tools and applications.

Responsibilities

• Provide strategic leadership and decision making on CSV strategy using Insmed’s risk-based approach.
• Provide oversight and manage multiple projects at the same time.
• Provide operational support like change controls, release management, and reviews of validated systems.
• Author CSV Documents (Validation Plans and Summary Reports).
• Assist/co-author requirements, testing, specification, and other validation project deliverables.
• Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.)
• Guide project team members on CSV projects ensuring team members follow laid out CSV plans.
• Provide real-time oversight and support during test execution and review executed protocols.
• Manage & maintain CSV documents in Veeva.
• Train, coach, and mentor GxP system owners.
• Support IT Change Control Manager – Creation of Agendas, minutes, and supporting CAB meetings.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees