Audit-Ready GMP Engineering Technical Writer

incog; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma Services is seeking an Engineering Technical Writer for our Fishers, IN facility. You will own engineering documentation quality across SOPs, work instructions, and validation documents, ensuring cGMP compliance and audit readiness.

You will collaborate with Production Engineers, Process Engineers, QA, and SME teams to deliver clear, accurate content and maintain a robust document library with indexing and traceability.

Qualifications

• Author, revise, and maintain GMP documentation (SOPs, work instructions, protocols, validation docs) per cGMP.
• Manage full document lifecycle in the DMS with change control coordination.
• Draft deviation investigations, root cause analyses, and CAPA documentation.

Responsibilities

• Translate complex technical content into clear, audit-ready documentation.
• Support training materials and visual work instructions for cross-functional teams.
• Assist during internal/client audits and regulatory inspections.

Skills

Technical writing

GMP documentation

Engineering documentation

DMS/EDMS

Microsoft Word

Education

Bachelor’s degree in a scientific, engineering, or technical discipline

Tools

EDMS

Microsoft Word

Microsoft Excel

Job description

INCOG BioPharma Services is seeking an Engineering Technical Writer for our Fishers, IN facility. You will own engineering documentation quality across SOPs, work instructions, and validation documents, ensuring cGMP compliance and audit readiness.

You will collaborate with Production Engineers, Process Engineers, QA, and SME teams to deliver clear, accurate content and maintain a robust document library with indexing and traceability.