GMP Documentation Engineer (Technical Writer)

INCOG BioPharma; Fishers (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

INCOG BioPharma is seeking an Engineering Technical Writer to own engineering documentation quality within the Engineering and Technical Operations team in Fishers, IN. The role ensures GMP-compliant content and audit-ready documentation across SOPs, work instructions, and validation reports.

The successful candidate will collaborate with Production Engineers, Process Engineers, QA, and SMEs, maintain the DMS lifecycle, and support deviations, CAPA, and master batch record sections.

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of technical writing experience in a regulated GMP environment.

Responsibilities

• Author, revise, and maintain GMP documentation (SOPs, work instructions, validation documents) per cGMP and INCOG standards.
• Manage the full document lifecycle in INCOG's DMS, including change control and archival processes.
• Draft deviation investigations, root cause analyses, and CAPA documentation.
• Develop engineering training materials and visual work instructions for cross-functional teams.
• Support audits and regulatory inspections with organized, traceable documentation.

Skills

Technical writing

GMP compliance

Regulatory understanding

Documentation management

Audit readiness

Cross-functional collaboration

Attention to detail

MS Word

Education

Bachelor's degree

Tools

EDMS

Job description

INCOG BioPharma is seeking an Engineering Technical Writer to own engineering documentation quality within the Engineering and Technical Operations team in Fishers, IN. The role ensures GMP-compliant content and audit-ready documentation across SOPs, work instructions, and validation reports.

The successful candidate will collaborate with Production Engineers, Process Engineers, QA, and SMEs, maintain the DMS lifecycle, and support deviations, CAPA, and master batch record sections.