Engineering Document Coordinator
College Station, Texas 77845 - US
Relocation costs will be covered
Summary: The Engineering Document Coordinator, under the supervision of the Director of Facility Engineering, will be responsible for various aspects of maintaining the engineering drawings, blue prints, P&IDs, technical manuals and other documents related to the equipment and facilities of the company, both hard copy and electronic.
- 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.
- Includes drafting preliminary changes to such drawings for approvals, as well as tracking drawings which are out-of-date and no longer accurate or obsolete.
- Responsible for working with engineers and equipment providers of utilities and equipment OEMs for up-to-date versions for turnover.
- Primarily be responsible for facilities and equipment documentation but the role may include GMP facilities and equipment not wholly owned by the company and will require liaison with engineers or document control personnel of other contractors and institutions.
- Will also work closely with other technicians and engineers who need access to the most recent documentation, such as Validation and Quality personnel.
- Responsible for taking the lead role in maintenance of the engineering documentation for 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.
- 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 company developed methods and procedures (engineering change control).
- 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 use and maintainability.
Required Skills & Abilities:
- Strong Computer Aided Design (CAD) skills, as well as experience with other computer designing programs such as Solidworks, etc.
- 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.
- 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.
- 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.
- Associates degree in preferably in Drafting, CAD Design, Solidworks, and/or other engineering design programs of study or related field, with two (2) years’ experience in an FDA or other regulated engineering document maintenance role; OR
- High School Diploma/GED with follow on education in a technical school or trade with four (4) years of qualified experience in an FDA or other regulated engineering document maintenance role.
- Experience should include 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.
Contact: Tom Lee (201) 843-4400 ext. 226