Technical Writer

INCOG BioPharma Services • Fishers, IN

2d • Onsite

About The Position

The Technical Writer 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.

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.

Nice To Haves

• Proficient in writing clear, concise, and accurate technical documentation.
• Strong understanding of GMP manufacturing processes and regulatory requirements.
• Excellent organizational skills with high attention to detail.
• Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
• Familiarity with documentation tools and electronic document management systems (EDMS).
• Ability to manage multiple projects and deadlines simultaneously.

Responsibilities

• 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, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
• 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, facilitate effective communication, and ensure that all documentation reflects the latest process developments and changes.
• 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. Continuously review and update documents to reflect process improvements, new technologies, and regulatory changes.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees