GMP Validation Writer: SOPs, Protocols & Compliance

Sentry BioPharma Services, Inc.; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Sentry BioPharma Services, Inc. is seeking a detail-oriented Validation Technical Writer to join our Validation team in Indianapolis, IN. The role focuses on ensuring accuracy, clarity, and regulatory compliance of GMP documentation for systems and facilities.

You will author validation reports (IQ/OQ/PQ), write SOPs, develop training materials, and maintain URS, risk assessments, and validation plans. Collaboration with cross-functional teams is essential to ensure audit readiness and

Qualifications

• Bachelor’s degree or 3+ years in life sciences technical writing.
• 1–2 years in a GMP-regulated environment preferred.
• Familiarity with computer systems qualification/validation preferred.
• Experience authoring validation documentation (URS, Risk Assessments, IQ/OQ/PQ) preferred.

Responsibilities

• Author and review validation reports (IQ/OQ/PQ) and summaries.
• Draft, update, and maintain SOPs and training materials for validation activities.
• Collaborate with cross-functional teams to ensure documentation accuracy.
• Create and maintain URS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and summaries.

Skills

Technical writing

Detail-oriented

GMP exposure

Education

Bachelor’s degree in a scientific/technical/engineering field

3 years life sciences technical writing experience

Tools

URS

IQ/OQ/PQ protocols

Validation documents

Job description

Sentry BioPharma Services, Inc. is seeking a detail-oriented Validation Technical Writer to join our Validation team in Indianapolis, IN. The role focuses on ensuring accuracy, clarity, and regulatory compliance of GMP documentation for systems and facilities.

You will author validation reports (IQ/OQ/PQ), write SOPs, develop training materials, and maintain URS, risk assessments, and validation plans. Collaboration with cross-functional teams is essential to ensure audit readiness and