Technical Writer

Technical Writer Role (Other titles can go by the following:)Investigator WriterSenior Technical WriterLead Documentation SpecialistRole SummaryWe are seeking a detail-oriented Technical Writer to create, review, and maintain high-quality technical documentation that supports manufacturing, quality, and regulatory processes. The ideal candidate will translate complex scientific and technical information into clear, concise, and accurate documents in compliance with industry standards and regulations.Key ResponsibilitiesDevelop, edit, and maintain technical documentation, including SOPs, batch records, process descriptions, work instructions, manuals, and training materials.Ensure all documents comply with GMP, ISO, and regulatory standards.Collaborate with cross-functional teams (Manufacturing, Quality, Engineering, R&D) to gather technical information and ensure accuracy.Support document control processes, including version control, approvals, and archiving.Review and update existing documentation to reflect changes in processes, equipment, or regulations.Assist in preparation of regulatory submission documents as needed.Ensure consistency, clarity, and readability of documents for end-users.Support training initiatives by providing clear and effective instructional materials.Required Qualifications & SkillsBachelor’s degree in Life Sciences, Engineering, Technical Communication, or related field.Proven experience as a technical writer in a regulated environment (pharmaceutical, biotech, or manufacturing preferred).Strong writing, editing, and proofreading skills.Ability to understand complex technical processes and translate them into clear documentation.Familiarity with regulatory requirements, GMP, ISO standards, and quality systems.Strong attention to detail, organization, and ability to manage multiple projects.Proficiency in Microsoft Office, document management systems, and technical authoring tools.Preferred/DesirableExperience in creating electronic batch records or using ELN/LIMS systems.Knowledge of process engineering, manufacturing operations, or bioprocessing.Familiarity with graphics or diagramming software for creating process flow diagrams.