GMP Validation Technical Writer — Protocols & SOPs Expert

Socket.dev; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Comprehensive benefits

Collaborative work environment

Professional growth opportunities

Job summary

Sentry BioPharma Services in Indianapolis seeks a detail-oriented Validation Technical Writer to join our Validation team. You will ensure accuracy, clarity, and regulatory compliance across GMP documentation, supporting IQ/OQ/PQ, SOPs, URS, risk assessments, and lifecycle plans.

The role requires a scientific/technical background, 3 years in technical writing in life sciences, GMP exposure, and ability to collaborate with cross-functional teams to deliver compliant documentation and auditable

Qualifications

• Bachelor’s degree in a scientific, technical, engineering, or related field preferred; or a minimum of 3 years of relevant experience in technical writing within life sciences.
• 1–2 years of experience in a GMP-regulated environment is preferred (or ability to learn regulatory/validation principles).
• Familiarity with computer systems and computer system qualification/validation is strongly preferred.
• Experience authoring or supporting validation documentation (URS, Risk Assessments, IQ/OQ/PQ, etc.) is preferred.

Responsibilities

• Author and review validation reports, including IQ, OQ, PQ protocols, summaries, and other validation documents.
• Draft, update, and maintain SOPs and training materials supporting validation activities.
• Collaborate with cross-functional teams to gather information and ensure documentation accuracy and consistency.
• Create and maintain validation documents (URS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and summaries).
• Research new equipment/processes to enhance understanding and translate to protocols and commissioning documents.
• Maintain documentation to support audit readiness and regulatory compliance.

Skills

Technical writing

Education

Bachelors/B.S. in scientific/technical field

Tools

GMP systems

Job description

Sentry BioPharma Services in Indianapolis seeks a detail-oriented Validation Technical Writer to join our Validation team. You will ensure accuracy, clarity, and regulatory compliance across GMP documentation, supporting IQ/OQ/PQ, SOPs, URS, risk assessments, and lifecycle plans.

The role requires a scientific/technical background, 3 years in technical writing in life sciences, GMP exposure, and ability to collaborate with cross-functional teams to deliver compliant documentation and auditable