CSV Analyst/Technical Writer

- Mid Level

Indianapolis, IN

About the position

The manager views this as someone who is more mid-level with 3-5 years of CSV Lead type experience. The manager wants someone who comes from CSV in a Life Sciences company. If they have work in R&D groups that would be the best scenario but not 100% needed. Someone who knows GxP and regulations would be great. This is true CSV work within IT systems (not lab equipment). He mentioned Veeva would be great but need someone who has a background in some document management systems. I think he said they use HP ALM. They want someone who has done validation IT from requirements, test scripts and traceability (UAT Testing).

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

• GMP experience is a plus.
• Benchling ELN experience is highly desirable.

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)