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 QualityDocs
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 QualityDocs
Working 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 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.