at Terumo BCT
Posted on Aug. 20, 2016
Under general engineering supervision, provides support by developing technical reports for Terumo BCT businesses, product lines, and corporate services directed at internal audiences.
* Obtains knowledge of the businesses' products and the therapies in which they are used.
* Obtains knowledge of industry, regulatory, linguistic, and publication standards and applies this knowledge to the completion of all projects.
* Works with internal customers to produce technical content that addresses technical problems of moderate complexity within areas of responsibility.
* Partners with subject matter experts to develop technical content in order to achieve specific and immediate business objectives; metrics will be used to determine effectiveness of content.
* Work with the SMEs to gather information about the products to create technical content.
* Manages content including writing new content, making changes/edits to existing content,
* Takes the initiative to report on project status and anticipates and alerts manager and internal customers of potential project difficulties.
* Assists in the maintenance of art, photo, and electronic and printed document files to meet departmental and regulatory requirements.
MINIMUM QUALIFICATION REQUIREMENTS
Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 3 years experience
* Experience with updating and understanding risk mitigations and pFMEAs (process Failure Mode Effects Analysis).
Experience with writing and editing process/equipment validation documents (IQ, OQ, PQ) Installation, Operational, and Performance qualifications for medical manufacturing processes.
Experience in assisting with or performing process and equipment validations (IQ, OQ, PQ) for medical device manufacturing.
Experience with automated and/or semi-automated manufacturing workcells.
Fluency with Microsoft Word, Excel, and Outlook.
Basic understanding of statistical methods and data analysis.
Preferred Skills: Familiarity with Minitab or a similar statistical analysis software package
Passing knowledge of PLCs (programmable logic controllers) and associated control software
* Ability to apply concepts of project management to writing projects.
* Possess knowledge of desktop publishing systems.
* Demonstrated ability to apply workflow processes and search.
* Understands the Information model and be willing to learn Terumo BCT's information model (Information types, content units, document structures, folder structure, and naming conventions).
* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Demonstrated ability to effectively use editing applications
EXPERTISE: Engineering - Mechanical
EDUCATION: Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
EXPERIENCE: Minimum 3 years experience