GMP CQV Validation Documentation Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

INCOG BioPharma Services seeks a Validation Technical Writer to own CQV documentation within the Engineering and Technical Operations team. You will craft, revise, and organize GMP documentation, including SOPs, work instructions, and validation lifecycle records, ensuring audit readiness and regulatory compliance.

Preferred candidates have 3+ years of technical writing in regulated environments (or 1 year with validation/engineering exposure).

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of technical writing experience, preferably in a regulated GMP environment, or 1 year with validation/engineering within the pharmaceutical/biotech industries.
• Strong understanding of GMP processes and regulatory requirements.
• Experience with EDMS and document control processes.

Responsibilities

• Author, revise, and maintain Validation GMP documentation per cGMP and INCOG standards.
• Manage the full document lifecycle in INCOG's DMS, including change control.
• Draft deviation investigations, root cause analyses, and CAPA documentation.
• Develop validation training materials, job aids, and visual work instructions.
• Conduct document gap assessments and periodic reviews for consistency.
• Serve as documentation readiness resource during audits and inspections.
• Support Validation Engineering activities to maintain validated state.
• Work flexible hours to support facility coverage.

Skills

Technical writing

GMP knowledge

Editing

EDMS tools

MS Word

MS Excel

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering

Tools

Veeva

Kneat

Job description

INCOG BioPharma Services seeks a Validation Technical Writer to own CQV documentation within the Engineering and Technical Operations team. You will craft, revise, and organize GMP documentation, including SOPs, work instructions, and validation lifecycle records, ensuring audit readiness and regulatory compliance.

Preferred candidates have 3+ years of technical writing in regulated environments (or 1 year with validation/engineering exposure).