MSAT Tech Writer

INCOG Biopharma Services in Indianapolis, IN is hiring an MSAT Tech Writer. This role is crucial for translating complex technical processes and data into clear, accurate, and accessible documentation. The Technical Writer will work closely with the MSAT engineers and other cross-functional teams to create comprehensive documentation that supports tech transfer, process validation, GMP floor support, and continued process verification, ensuring that all materials meet regulatory and quality standards.

At INCOG, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.

Job Function:

• Develop, author, and maintain a wide variety of technical documents, including but not limited to Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bill of Materials, and Processing Forms.
• Ensure all documentation is compliant with GMP standards and meets regulatory requirements, particularly for Process Performance Qualification and Continuous Process Verification.
• Work closely with MSAT engineers, project teams, and clients to gather necessary technical information, and facilitate effective communication.
• Translate technical data and process monitoring results into comprehensible reports, identifying trends, proposing actions, and supporting troubleshooting efforts with clear, actionable documentation.
• Establish and maintain documentation standards to ensure consistency across all technical documents.
• Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols.

Candidate Requirements:

• Associate’s degree in an English major or in scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Engineering). A bachelor’s degree is preferred.
• Minimum of 0 - 3 years of experience in technical writing within a GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations