CSV Specialist

Role Summary

A CSV Specialist responsible for leading CSV strategy with a risk-based approach, overseeing multiple projects, and ensuring the compliance and validation of computerized systems throughout their lifecycle. The role involves guidance on release management, change control, and audit trails, with hybrid work based out of the Bridgewater HQ and opportunities for remote work when appropriate.

Responsibilities

• Engage on CSV projects as a key team member; provide guidance to ensure computerized systems are deployed following lifecycle management and remain in a validated state per SOPs, regulatory and security requirements.
• Ensure compliance and operational efficiency of validated systems through release management, change control, periodic reviews, and audit trail reviews.
• 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 and maintain CSV documents in Veeva.
• Train, coach, and mentor GxP system owners.

Qualifications

• Required: Bachelor’s Degree and 3+ years’ experience in a management validation role with responsibility for computer systems (examples include LIMS, Empower, BMRAM, Chromeleon, environmental monitoring systems, and other Lab systems).
• Preferred: 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 documents; experience with Veeva QualityDocs/QMS; knowledge of FDA Computer Software Assurance (CSA) concepts; basic understanding of data integrity (ALCOA+) principles; strong customer service skills; ability to multi-task and prioritize; experience with GxP AI tools and applications.

Skills

• Technical writing
• Project management and multi-project oversight
• GxP and CSV regulatory knowledge
• Documentation management (e.g., Veeva)
• Communication and collaboration across cross-functional teams

Education

• Bachelor’s Degree (field related to life sciences or engineering typically required)