FUJIFILM DIOSYNTH BIOTECHNOLOGIES CAD & Engineering Document Management Specialist in COLLEGE STATION, Texas

Essential Functions: Subject Matter Expert for CAD systems, software, processes and procedures. FDBT s Main Point of Contact for CAD and engineering document management service provider. System owner for all drawing management software s, e.g. AutoCAD, Revit, etc. as required. Responsible of creating and/or updating engineering drawings and supporting documentation in adherence with CAD and A/E Firm Project Standard practices and local procedures. Be able to prepare complex drawings, drawing layouts, designs and/or technical illustrations, etc. utilizing appropriate methods such as CAD/CAM technology or others as needed. Responsible for taking the lead role in maintenance of the engineering documentation for FDBT facilities and equipment. This includes maintaining existing documentation for Mobile Clean Rooms (MCRs) (independent clean rooms with redundant HVAC systems and controls), qualified utility systems, such as pure water systems, clean steam, and bio-waste systems, and a wide variety of bio processing equipment. Ensure revision control of CAD files, secures retention of CAD files and format review of all drawings. Ability to make changes and track changes to independent systems that may be overlays on other existing systems and architecture as required. (Revision Control). Interface with vendors, engineers, and OEM providers, both foreign and domestic for obtaining original correct drawings, and making changes to those drawings through FDBT developed methods and procedures (engineering change control). Be able to develop local procedures, standards, job aids, URS and/or best practices as required to develop the computer aided design function and the engineering document management strategy. Fully understand engineering and drafting symbols and icons used in P&IDs, blueprints and legends, as well as architectural blueprints. Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines. Able to work with other engineers and validation contractors in directing and providing oversight of specialized contractors to ensure produced drawings and documents are provided in acceptable format for FDBT use and maintainability. Other duties as assigned. Required Skills & Abilities: Strong Computer Aided Design (CAD) skills, as well as experience with other computer designing programs such as Solidworks, Revit, etc. Solid understanding of engineering document management process, organization, revision, control and archiving. Solid understanding of revision control, tracking changes by revision control, tracking changes through unapproved versions as well as approved versions and maintaining effective archives of revisions, etc. Solid understanding of CAD principles, Drawing Management and regulated document lifecycle. Strong written, verbal and interpersonal communication skills to develop and draft clear procedures for documentation control and revision control. Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility. Ability to work quickly and effectively without constant supervision. Ability to convince management on courses of action and decision making with minimal assistance using both written and verbal methods. Strong knowledge of MS Office products (Word, Excel, Outlook, PowerPoint). Experience working and communicating with maintenance trades such as HVAC, Electrical, Mechanical, structural, etc. This is a new role, and will require a high level of personal organizational skills and experience. The successful candidate must have a vision of a final state, fully organized engineering documentation system, for controlling changes, revisions and revision control, and ability to execute the vision with little supervision. Working Conditions & Physical Requirements: The physical demands described here are representative of those that