CAD & Engineering Document Management Specialist
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: May 8, 2022
Job Description:
Overview Summary: - The CAD & Engineering Document Management
Specialist, under the supervision of the Director of 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, blueprints, 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out-of-date and no longer accurate or obsolete.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. - External
US Essential Functions:
- Be Fujifilm's Subject Matter Expert for CAD systems, software,
processes and procedures.
- Be Fujifilm's Main Point of Contact for CAD and engineering
document management service provider.
- Be the System owner for all drawing management software's, e.g.
Meridian, 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 (e.g. 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 archive.
- 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.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory.
- This position may require off shifts, weekends and/or holidays
support.Supervisory Responsibilities: - N/AMinimum Qualifications:
- Associates degree preferably in Drafting, CAD Design,
Solidworks, and/or other engineering design programs of study or
related field, with a minimum of 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.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
or call 979-431-3500. #LI-SB2
Keywords: FUJIFILM Holdings America Corporation, College Station , CAD & Engineering Document Management Specialist, Executive , College Station, Texas
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