Summary: The CAD & Engineering Document Management Specialist, under the supervision of the Director or Associate Director, Facility Engineering, will be responsible to proactively develop the computer aided design function and properly define the engineering document management strategy for the College Station site. Perform routine to moderately complex design and drafting functions in support of various areas such as engineering, manufacturing, facilities, validation, etc. Perform various aspects of maintaining the engineering drawings, blue prints, P&IDs, technical manuals and other documents related to the equipment and facilities of FDBT, both hard copy and electronic.
Responsibilities include verification of existing equipment and facilities documents in cooperation with contractors, engineers and validation personnel, and tracking the changes made to those documents under authorized engineering change control. This will include facilities drawings, OEM and Vendor drawings, and producing revisions to such drawings. This will also include drafting preliminary changes to such drawings for approvals, as well as tracking drawings which are out-of-date and no longer accurate or obsolete. This position will also be responsible for working with engineers and equipment providers of utilities and equipment OEMs for up-to-date versions for turnover.
Primarily be responsible for FDBT facilities and equipment documentation but the role may include GMP facilities and equipment not wholly owned by FDBT and will require liaison with engineers or document control personnel of other contractors and institutions. This position will also work closely with other technicians and engineers who need access to the most recent documentation, such as Validation and Quality personnel.
- 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 must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate portable tools, test instruments, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
- Have a normal range of vision.
- The ability to regularly lift and/or move up to 50 pounds.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may be On-Call for Facility monitoring.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory
Supervisory Responsibilities: N/A
- Associates degree preferably in Drafting, CAD Design, Solidworks, and/or other engineering design programs of study or related field, with four (4) years of qualified experience in an FDA or other regulated CAD & engineering document management role; OR
- High School Diploma/GED with continued education in a technical school or trade with eight (8) years of qualified experience in an FDA or other regulated CAD & engineering document management role.
- Experience should include drawings and document management for clean utilities, architecture, and equipment.
- Experience in maintaining changes and revision control in a research or manufacturing facility.
- Knowledge of design and construction methods of bio-processing equipment, clean utilities, and other equipment.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.