This Tech Writer 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.
Essential Job Functions:
- 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.
Special Job 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.
Additional Preferences:
- 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.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
