Find & Apply For Technical Writer Jobs in Fishers, Indiana

INCOG BioPharma Services Apply Now Engineering Technical Writer Fishers, IN, US • Posted 5 hours ago • Updated 5 hours ago Full Time On-site Fitment Dice Job Match Score™ To see how well you match this job, please log in or create an account . Once logged in, be sure to complete your profile to get the most accurate match score. Job Details Skills Embedded Systems IT Operations Regulatory Compliance Quality Assurance IT Service Management Operational Excellence Forms

IQ OQ PQ

Document Engineering Specification Gathering Functional Design Good Manufacturing Practice DMS Version Control Routing Change Control Inspection Root Cause Analysis Corrective And Preventive Action Training Auditing Organized Meta-data Management Pharmaceutics Biotechnology Writing Technical Writing GMP Manufacturing Organizational Skills Attention To Detail Collaboration Documentation Document Management Microsoft Word Microsoft Excel Management Scratch

SAP BASIS

Employment Authorization Physical Layer Embedded Systems IT Operations Regulatory Compliance Quality Assurance IT Service Management Operational Excellence Forms

IQ OQ PQ

Document Engineering Specification Gathering Functional Design Good Manufacturing Practice DMS Version Control Routing Change Control Inspection Root Cause Analysis Corrective And Preventive Action Training Auditing Organized Meta-data Management Pharmaceutics Biotechnology Writing Technical Writing GMP Manufacturing Organizational Skills Attention To Detail Collaboration Documentation Document Management Microsoft Word Microsoft Excel Management Scratch

SAP BASIS

Employment Authorization Physical Layer Show more Summary Description 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 technical writing experience, preferably within a regulated GMP environment, and ideally in 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. By submitting your resume and details, you are declaring that the information is correct and accurate. Employers have access to artificial intelligence language tools ("AI") that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id:

80184786

Position Id:

f10a6f1be8e29ff93d8d0fcaf3ba7784 Posted 5 hours ago Create job alert Never miss an opportunity! Create an alert based on the job you applied for. Create alert Similar Jobs INCOG BioPharma Services Process Validation Engineer Fishers, Indiana • Today Description TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process Validation Engineer will be responsible for supporting all facets of Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide technical support to ensure robust and reliable production processes are established and maintained. This position wil Full-time Eli Lilly and Company Engineer - Process Automation / IDAP Site Expansion - Assembly Indianapolis, Indiana • Today At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i Full-time

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Position Overview:

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Key Responsibilities:

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