Hiring for Technical Writer / Document Controller (CSV AND Kneat Focus) || Indianapolis, IN

Title: Technical Writer / Document Controller
(CSV Focus)
Location: Indiana, IN (Hybrid)
On-site Requirement: As required based on project phase

Purpose of the Role:
The Technical Writer / Document Controller will support documentation and CSV
deliverables across multiple projects within the client s Foundry Program.

Key Responsibilities:
Support validation activities as per the approved Validation Plan and CSV
documentation standards.
Assist in drafting, updating, and maintaining validation deliverables and templates.
Ensure all project documents adhere to standardized templates and naming
conventions.
Manage document routing, reviews, and approvals within the electronic document
management system.
Coordinate review cycles and track document status for efficient closure.
Support preparation and routing of testing artifacts for approval in Kneat.
Generate reports and queries to support document tracking and progress reporting.
Update spreadsheets, trackers, and SharePoint content as directed.
Collaborate with Validation Leads and SMEs to update custom test content and
assemble test sets in Kneat.

Requirements:
Bachelor s degree in Engineering or equivalent preferred.
Minimum 2 years of experience supporting CSV activities within the pharmaceutical
industry.
Familiarity with Kneat or other electronic test/document management systems
preferred.
Excellent attention to detail, teamwork, and organizational skills.
Strong proficiency in Microsoft Office and web-based documentation tools.