CSV Specialist

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:
•\tEngage on CSV Projects as a key team member. 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.
•\tEnsure compliance and operational efficiency of validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.

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:

• 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
• Route CSV documents for approval(s)
• Manage & maintain CSV documents in Veeva
• Train, coach, and mentor GxP system owners.

Who You Are:

• You have a Bachelor's Degree along with 3+ years' experience in a management validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, Chromeleon, environmental monitoring systems, and other Lab systems.
  You are or you also have:
• Experience in lab equipment and lab business processes is preferred.
• 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 is preferred.
• Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.
• Basic understanding of data integrity (ALCOA+) principles.
• Strong customer service skills for internal and external customers.
• Ability to multi-task and prioritize efforts effectively.
• Experience with GxP AI tools and applications is a plus.

Where You'll Work

This is a hybrid role based out of our Bridgewater HQ office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.

#LI-JTI

#LI-Hybrid

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 [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.