Technical Writer — GxP & Validation Documentation

Technical Writer — GxP & Validation DocumentationLocation: Onsite Indianapolis, IN Industry: PharmaceuticalJob OverviewTheoris is looking for a Technical Writer specializing in GxP and validation documentation. This person 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, compliance-ready content.ResponsibilitiesAuthor and maintain SOPs, IQ/OQ/PQ protocols and reports, and Requirements Traceability Matrices (RTMs) within QualityDocsTranslate complex system configurations, API behaviors, Veeva Vault Safety workflows, and integration logic into GxP-compliant documentationPartner with engineers and SMEs to extract technical knowledge and produce structured, compliance-ready contentManage document lifecycle activities including version control, review cycles, and change-controlled updatesSupport cross-functional collaboration across technical and compliance teamsRequirements:3+ years of technical writing experience in a GxP-regulated pharmaceutical, biotech, or medical device environmentProven experience authoring IQ/OQ/PQ protocols, SOPs, and RTMs in an EDMS such as QualityDocsWorking knowledge of CSV/CSA principles and applicable regulations (21 CFR Part 11, EU Annex 11, GAMP 5)Conceptual understanding of REST/GraphQL APIs, authentication flows, and CI/CD pipelines sufficient to document them accurately — coding not requiredFamiliarity with Veeva Vault Safety or similar pharmacovigilance systems preferredBest-In-Class-BenefitsWe 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 accrual Paid holidays Excellent cash-based referral programAbout TheorisOur 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.