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CSV Engineer

Katalyst Healthcares and LifesciencesRaritan, NJ🇺🇸United StatesPosted 14 Aug 2026

Quick Overview

Work Type
Hybrid
Level
Mid Senior

Job Description

Summary :

Roles & Responsibilities :
  • Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
  • Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
  • Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
  • Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
  • Demonstrated application of risk-based validation and risk management practices.
  • Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
  • Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
  • Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
  • Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
  • bility to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
  • Primary Language required: English. Strong verbal and written communication skills.
  • bility to work with dispersed/remote teams and support several projects simultaneously.
  • Experience with Acquisitions/Separations/ Divestiture efforts is desirable.

Skills

Agile
Jira

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