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TEKsystemsposted 19 days ago
$35 - $52/Yr
Mid Level
Indianapolis, IN
Resume Match Score

About the position

The Technical Writer/CSV Analyst position is focused on system validation, specifically around validating IT systems to support the large molecule group in documenting validation processes for their Electronic Lab Notebook (ELN) system. This role emphasizes the importance of Computer System Validation (CSV) experience and requires the candidate to work independently while engaging with multiple stakeholders, including IT, R&D, Quality & Validation, and Product Owners.

Responsibilities

  • Develop and author validation documentation for the large molecule group, including User Requirements Specifications (URS), Functional Specifications, Validation and Test Plans, IQ/OQ/PQ protocols, and Standard Operating Procedures (SOPs).
  • Ensure validation documentation meets GxP and compliance standards.
  • Create and execute testing strategies and scripts to support system validation efforts.
  • Collaborate with IT, R&D, Quality & Validation, and Product Owners to gather requirements and document workflows.
  • Manage structured document control and version management within a Document Management System (DMS).

Requirements

  • 3+ years of experience in technical writing within a regulated industry (Pharma, Biotech, Animal Health).
  • Strong CSV (Computer System Validation) experience, specifically in validating IT systems.
  • Experience with system validation, testing protocols, and technical documentation.
  • Prior experience with electronic Lab Notebooks (ELN) (Benchling preferred, but any ELN experience acceptable).
  • Strong knowledge of GxP, 21 CFR Part 11, and validation documentation processes.
  • Ability to work independently while engaging with multiple stakeholders.
  • Proficiency in MS Office, Visio, and Document Management Systems (DMS).

Nice-to-haves

  • Experience working in R&D groups within Life Sciences companies.

Benefits

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)
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