We are looking for an Engineering Technical Writer who is a detail-oriented documentation professional with a strong technical background and a thorough understanding of GMP documentation standards in a regulated pharmaceutical manufacturing environment. Embedded within INCOG BioPharma's Engineering and Technical Operations team, the Engineering Technical Writer is the primary owner of engineering documentation quality, consistency, and compliance.
This role partners closely with Production Engineers, Process Engineers, Manufacturing Equipment Technicians, Quality Assurance, Technical Services, and Operations to translate complex technical content into clear, accurate, and audit-ready documentation. The Engineering Technical Writer plays a critical role in ensuring that INCOG's engineering documentation infrastructure supports operational excellence, regulatory readiness, and long-term institutional knowledge across all manufacturing areas and suites.
Essential Job Functions:
- Author, revise, and maintain engineering GMP documentation (SOPs, work instructions, prep forms, IQ/OQ/PQ protocols/reports, validation documents, engineering specs, and functional design documents) in accordance with cGMP and INCOG standards, collaborating with Production Engineers, Process Engineers, Manufacturing Equipment Technicians, and SMEs to translate technical input into clear, compliant content
- Manage the full document lifecycle in INCOG's DMS (initiation, periodic review, revision control, approval routing, and retirement), including change control documentation coordinated with Quality, Manufacturing, and Engineering to ensure change packages are complete and inspection-ready
- Structure and draft deviation investigations, root cause analyses, and CAPA documentation, and provide technical writing support for master batch record sections covering equipment setup, cleaning, and operation
- Develop engineering training materials, job aids, and visual work instructions to support competency development across PrE, PE, and MET teams
- Conduct document gap assessments and periodic reviews, applying INCOG's documentation style standards to resolve discrepancies and maintain consistency across engineering documents
- Serve as a documentation readiness resource during internal/client audits and regulatory inspections, and maintain an organized, traceable documentation library with indices and metadata for efficient retrieval
- Work flexible hours to support manufacturing facility coverage as needed
Special Job Requirements:
- Bachelor’s degree in a scientific, engineering, or technical discipline.
- Minimum of 3 years of experience in technical writing within a regulated 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).
- Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
- 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.
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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