GMP Engineering Tech Writer | Documentation & Compliance

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma Services is seeking an Engineering Technical Writer to own engineering GMP documentation quality and compliance. You will work with Production, Process, and Quality teams to translate complex content into clear, audit-ready documents, and manage lifecycle activities in INCOG's DMS.

The role emphasizes strong attention to detail, regulatory readiness, and collaboration across engineering and operations to support institutional knowledge in a GMP biopharma setting.

Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of technical writing experience in a regulated GMP environment.
• Experience with GMP documentation standards and regulatory readiness.

Responsibilities

• Author, revise, and maintain engineering GMP documentation (SOPs, work instructions, and QC/validation docs) per cGMP and INCOG standards.
• Manage the full document lifecycle in INCOG's DMS, including change control and approvals.
• Draft deviation investigations, root cause analyses, and CAPA documentation.
• Develop engineering training materials and visual work instructions for multiple teams.
• Conduct document gap assessments and ensure consistency across documents.
• Support audits and regulatory inspections with organized documentation.

Skills

GMP Technical Writing

Document Lifecycle Management

CAPA documentation

Training materials development

Regulatory audits support

Cross-functional collaboration

Education

Bachelor's degree in scientific/engineering/technical discipline

Tools

Microsoft Word

Microsoft Excel

EDMS

Job description

INCOG BioPharma Services is seeking an Engineering Technical Writer to own engineering GMP documentation quality and compliance. You will work with Production, Process, and Quality teams to translate complex content into clear, audit-ready documents, and manage lifecycle activities in INCOG's DMS.

The role emphasizes strong attention to detail, regulatory readiness, and collaboration across engineering and operations to support institutional knowledge in a GMP biopharma setting.