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Tech Writer - Tech Services Summary

The Tech Writer will support the TSMS department by creating and maintaining technical documentation for technical transfer and manufacturing activities in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will work closely with TSMS engineers and cross-functional teams to produce clear, accurate, and compliant documentation that supports manufacturing operations and regulatory requirements.

Essential Job Functions:

• Develop, author, and maintain technical documents including Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bill of Materials, and Processing Forms under guidance of senior staff

• Support creation of technical specifications, batch records, forms, and reports ensuring information is clear, detailed, and usable by both technical and non-technical stakeholders

• Ensure all documentation complies with GMP standards and meets regulatory requirements

• Collaborate with TSMS engineers, and project teams to gather necessary technical information and ensure documentation reflects current process developments and changes

• Assist with translating technical data and process monitoring results into comprehensible reports under supervision of senior technical staff

• Support establishment and maintenance of documentation standards to ensure consistency across technical documents

• Assist in creating user manuals, training guides, and support materials to aid staff education regarding GMP manufacturing processes and protocols

• Review and update existing documents to reflect process improvements, new technologies, and regulatory changes

• Assist with document control activities and maintain accurate records in electronic document management systems (EDMS)

• Support cross-functional teams by providing clear documentation that facilitates effective communication across departments

• Participate in document review processes and incorporate feedback from technical subject matter experts

• Other responsibilities as required

Special Job Requirements:

• High School diploma required

• Associate's degree in English, Technical Writing, or scientific/technical discipline preferred

• 0-2 years of experience in technical writing, preferably in a GMP environment or pharmaceutical/biotechnology industry

• Strong writing skills with ability to create clear, concise, and accurate technical documentation

• Basic understanding of GMP manufacturing processes and regulatory requirements preferred

• Excellent organizational skills with high attention to detail

• Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and familiarity with documentation tools

• Ability to manage multiple assignments and deadlines with guidance

• Strong research and information gathering skills 
  

INCOG’s Benefits:

·       Paid vacation days, amount based on tenure, and paid sick time

·       11 observed holidays

·       401(k) plan with company match up to 3.5% of salary, vested immediately

·       Choice of health & wellness plans

·       FSA and HSA programs

·       Dental & vision care

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.

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.

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