Technical Writer

Sentry BioPharma Services Inc•Indianapolis, IN

About The Position

Sentry BioPharma Services provides pharmaceutical product management for temperature sensitive medications. Sentry maintains drug products at specific temperatures, labels, kits, packages and distributes these products into and out of fifty (50) countries for a wide variety of pharmaceutical companies. Sentry’s newest product offerings include a full stability program, aliquoting for further testing and analytics for stability via its laboratory operations at Sentry Laboratory Services. We are seeking a detail-oriented Validation Technical Writer to join our Validation team. In this role, you will play a vital part in ensuring the accuracy, clarity, and compliance of documentation related to GMP-regulated systems and facilities. Your expertise will support our commitment to maintaining high-quality standards and regulatory readiness through precise and well-structured documentation.

Requirements

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 demonstrated ability to quickly learn regulatory and 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 internally review validation reports, including IQ, OQ, PQ protocols, summaries, and other validation documents.
Draft, update, and maintain Standard Operating Procedures (SOPs) to ensure clarity and compliance and develop and revise training materials to support validation activities and ensure team understanding.
Collaborate with cross-functional teams to gather necessary information and ensure documentation accuracy and consistency.
Create and maintain a variety of validation documents, including User Requirements Specifications (URS), Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, and IQ/OQ/PQ summaries. Contribute to and review System Design Specifications, SAT/SOO documents, and Lifecycle Management Plans.
Perform deep research on new equipment, systems, or current processes to enhance technical understanding and translate that understanding to protocols, SOPs, and commissioning documents.
Keep validation documents, templates, and records current to support audit readiness and adapt to evolving quality and regulatory expectations. Respond to feedback on GMP documents by making logical updates. Maintain documentation in accordance with regulatory requirements and company standards.