Interact with Engineers, R&D, and Operations personnel to create and update Work Instructions, Work Flows, Process Maps, User Guides, Training materials and manuals for production, maintenance, and engineering use.
• Write, create, and update detailed manufacturing operational procedures and documents.
• Use Product Lifecycle Management software to complete tasks and drive closure of document and engineering change orders on behalf of the Production department
• Edit, standardize, or make changes to material prepared by other personnel.
• Research and translate technical information into manuals and/or web-based documents for non-technical and technical users.
• Draft or assist with production related nonconformance reports
• Organize materials and complete writing assignments according to set standards regarding order, clarity, conciseness, style, and terminology.
• Collaborate within and across departments to collect and interpret input to be incorporated into documents.
• Collaborate with change management to continuously improve process to support business needs.
• Experience writing technical reference materials, procedure manuals, and/or end user guides required.
• Experience writing technical procedures for manufacturing operations required.
• Experience in writing technical documents for bio tech industry desired.
• Ability to synthesize and describe complex data for multiple audiences.
• Proven to work both independently and collaboratively with other team members delivering quality documentation with aggressive time lines required.
• Strong verbal and written communications skills required.
• Good planning, organizational, and reporting skills required.
• Proven ability to work in a fast-paced environment and react quickly to urgent situations required.
• Strong personal computer skills required.
• Strong working knowledge of Microsoft Suite (Word, Excel, PowerPoint, Project, and Visio) required.
• Experience with PLM software and change management process desired.
1-2 years of technical writing experience in a cGMP environment (e.g. medical device, IVD, or pharmaceutical industry) with a Bachelor’s Degree.
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