Technical Writer
About the Role
The Technical Writer supports documentation creation and revision activities related to production processes, equipment operation, cleaning, testing, forms, logs, attachments, checklists, and other controlled documents. This role assesses the training and capability impact of changes, captures critical operational knowledge, improves usability of instructions, and supports effective implementation of process changes. The position works closely with cross-functional partners to ensure documentation is accurate, compliant, easy to follow, aligned with root cause and CAPA needs, and effective for employees.
Responsibilities
- Recommend, draft, revise, and maintain SOPs, standard work instructions, work aids, logs, forms, attachments, checklists, and other controlled documentation.
- Prepare clear written descriptions of work processes using approved formats, templates, and style expectations.
- Fulfill requests from the document change request process and communicate barriers, resource needs, and timeline risks.
- Ensure document content meets applicable quality, compliance, operational, and site requirements.
- Evaluate documentation changes to determine training, retraining, communication, or performance support needs.
- Identify affected roles, departments, and employee populations impacted by procedural or process changes.
- Partner with Training & Development, Master Trainers, Quality, Engineering, and Operations to support effective change implementation.
- Support readiness planning for engineering changes, continuous improvement projects, CAPAs, new equipment, and procedural updates.
- Interview and facilitate discussions with subject matter experts to understand work processes, critical steps, decision points, common errors, and process gaps.
- Capture tacit and tribal knowledge from experienced employees and translate it into standardized, usable documentation and learning resources.
- Support development of knowledge repositories, visual references, job aids, and standardized resources that improve consistency across teams or sites.
- Identify inconsistencies, ambiguity, or missing information in existing procedures and collaborate with SMEs to resolve gaps.
- Improve documentation usability by reducing complexity, clarifying critical steps, and applying human performance improvement principles.
- Develop visual work instructions, process maps, flowcharts, equipment annotations, job aids, photographs, and other visual supports.
- Assess whether documentation is practical, understandable, and effective for intended users.
- Participate in technical writer, continuous improvement, and CAPA-related meetings to understand priorities and rationale for procedural changes.
- Contribute to CAPA-related projects by ensuring documentation aligns with root cause and intended corrective or preventive action.
- Support continuous improvement by identifying document-related barriers that could contribute to errors, deviations, rework, or inconsistent execution.
- Support development of digital job aids, micro-learning resources, LMS-supporting content, and electronic performance support materials.
- Use approved technology and AI-assisted content tools responsibly to improve drafting, version comparison, SME interview summaries, consistency, and productivity.
- Measure and improve documentation effectiveness by gathering feedback, reviewing usability, and assessing impact on execution, errors, training, or recurrence prevention.
Requirements
- Bachelor’s degree in Technical Writing, Communications, Education, Instructional Design, Engineering, Manufacturing, Science, or a related field preferred.
- Minimum three (3) years of experience in technical writing, manufacturing operations, training, quality systems, or regulated documentation.
- Experience working in FDA-regulated, cGMP, pharmaceutical, nutrition, medical device, food manufacturing, or similar regulated environments preferred.
- Proficiency with Microsoft Office applications; ability to learn and utilize document management systems, learning management systems (LMS), and digital content tools.
- Demonstrated ability to manage multiple priorities, collaborate across functions, gather information from subject matter experts (SMEs), and communicate project needs and challenges.
Preferred Competencies
- Knowledge of adult learning principles, task analysis, performance-based training, and knowledge transfer methodologies.
- Experience conducting SME interviews, capturing institutional knowledge, and standardizing documentation across teams and locations.
- Understanding of quality and process improvement concepts, including CAPA, root cause analysis, risk assessment, process mapping, and workflow documentation.
- Ability to develop visual and digital learning materials, including work instructions, flowcharts, job aids, equipment annotations, photography, micro-learning content, and LMS-based training.
- Strong change management skills, including stakeholder engagement, communication planning, implementation support, and continuous improvement practices.
- Experience leveraging AI and content automation tools to support document creation, content review, version comparison, and standardization efforts.
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. We are proud to be included in the Forbes list of "America's Best Employers by State 2024".