CSV Specialist

Role Summary

CSV Specialist

Responsibilities

• 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.
• Provide strategic leadership and decision making on CSV strategy using Insmed‚Äôs 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.

Qualifications

• 3+ years‚Äô 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.

Education

• Bachelor's in Computer Science, Engineering, Life Sciences, or a related field.