Technical Writer GxP & Validation Documentation

Position: Technical Writer   GxP & Validation Documentation
JOB TITLE: Technical Writer-Gxp & Validation Documentation
LOCATION: Onsite Indianapolis, IN
INDUSTRY: Pharmaceutical

JOB SUMMARY: Theoris is looking for someone who will author and maintain validation-ready documentation while working closely with engineers, product managers, and subject matter experts to translate complex technical systems into clear, auditable content.

RESPONSIBILITIES:

• Author and maintain SOPs, IQ/OQ/PQ protocols and reports, and Requirements Traceability Matrices (RTMs) within Quality Docs
• Translate complex system configurations, API behaviors, Veeva Vault Safety workflows, and integration logic into GxP-compliant documentation
• Partner with engineers and SMEs to extract technical knowledge and produce structured, compliance-ready content
• Manage document lifecycle activities including version control, review cycles, and change-controlled updates
• Support cross-functional collaboration across technical and compliance teams

REQUIREMENTS:

• 3+ years of technical writing experience in a GxP-regulated pharmaceutical, biotech, or medical device environment
• Proven experience authoring IQ/OQ/PQ protocols, SOPs, and RTMs in an EDMS such as Quality Docs
• Working knowledge of CSV/CSA principles and applicable regulations (21 CFR Part 11, EU Annex 11, GAMP
  5)
• Conceptual understanding of REST/Graph
  
  QL APIs, authentication flows, and CI/CD pipelines sufficient to document them accurately — coding not required
• Familiarity with Veeva Vault Safety or similar pharmacovigilance systems preferred

SKILLS & COMPETENCIES

• Strong written and verbal communication skills
• Exceptional attention to detail and commitment to accuracy
• Self-directed with the ability to manage multiple projects and deadlines
• Comfortable working across both technical and compliance-focused teams
• Willingness to learn new technologies quickly

Best-In-Class-Benefits:
We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:

• Robust Health Insurance
• 401(k) plan
• PTO
• Paid holidays

About Theoris: Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections.

This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.