CSV Specialist

Insmed Inc. • Bridgewater, NJ • 2h ago

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 four 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: Engage 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. Ensure compliance and operational efficiency of validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.What You'll Do: Responsibilities (Essential Role Responsibilities): Responsibilities will include, but not necessarily limited to the following: 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 Route CSV documents for approval(s) Manage & maintain CSV documents in Veeva Train, coach, and mentor GxP system owners.Who You Are: Position Requirements (Required and/or Preferred Skills, Experience and Education): 3+ years' hands on 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 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. Bachelor's in Computer Science, Engineering, Life Sciences, or a related field.#LI-JTI #LI-HybridPay Range:$100,000.00-139,133.00 AnnualLife at InsmedAt 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

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