Technical Writer II

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As the company continues to grow, we are seeking a Technical Writer II in Rochester, NY. The Technical Writer II will be part of the engineering team responsible for the modification of production lines and commissioning of equipment in Rochester NY. This position will be responsible for managing change documentation for the team and assisting with process and procedure development. The candidate will assess risks and will drive quality related decisions. Tracking, monitoring, and engaging engineers on tasks required by quality.

This position is in Rochester, NY.

R esponsibilities

• Responsible for reviewing, editing and/or creating pharmaceutical/medical/technical documentation (e.g. batch records, specifications, procedures, SOPs, work instructions, forms etc.) for manufacturing and lab operations, providing clear and correct instructions for site processes and procedures. Interview and confer with SMEs in cross functional groups, observing production, developmental, and experiment activities to develop and/or revise documentation content for completeness and correctness.
• Edit, standardize, or make changes to documents prepared by SMEs or other company personnel. Use Microsoft Word for editing and/or creating documents and demonstrating proficiency with templates and custom formats. Ensure verbiage is easy for manufacturing operators and formulation technicians to understand.
• Review established documentation and recommend revisions or changes in scope, format, and content. Provide direction with the use of best practices for documentation hierarchy during documentation creation process.
• Write document change documentation within a computer-based change management software (WindChill). Maintain records and files of work and revisions. Develop specific goals and plans to prioritize, organize, and accomplish objectives. Manage the documentation, change order, and change control processes. Manage new documentation and revised documentation through lifecycle within a document management system.

The Individual

• A Bachelor's Degree is required, preferably with an educational background in Science, Engineering, Manufacturing.
• Minimum 5 years of experience technical writing and/or procedure development. A combination of education and experience may be considered.
• FDA regulated Manufacturing and/or Quality experience is strongly preferred.
• Experience within the Ortho Windchill change management system/process is strongly preferred.
• Excellent communication skills; verbal and written.
• Proficiency Microsoft Office (Word Required: Excel and Visio Preferred).
• Strong knowledge of English language including the meaning and spelling of words, rules of composition, and grammar required.
• Detail orientated: Must be able to create detailed instructions.
• Strong prioritization, multitasking, and time management skills.

EOE/AA Disability/Veteran

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