Facilities Engineer II
The Facilities Engineer II, under the supervision of the Associate Director, Facility Engineering, will be responsible for performing various aspects of engineering, operational and troubleshooting support for facilities, utilities and process equipment including but not limited to bioreactors, fermenters, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam boilers, water purification and distillation units, waste water treatment systems, etc. at the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). This position will apply engineering principles to monitor the running condition of complex equipment, and use technical manuals, on-line resources and OEM representatives to maintain the equipment with a minimum of downtime. This position will also work closely with manufacturing resources, validation, QA/QC and maintenance/calibration technicians to help maintain complex process equipment operational and troubleshoot to identify issues when needed. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will also support P&ID development, maintenance strategies development, equipment life cycle development, any software and/or hardware upgrades and equipment commissioning/qualification activities as required. This position may also assist in the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.
- Responsible for providing engineering, operational and troubleshooting support to facilities, utilities and process equipment as needed.
- Responsible for monitoring complex equipment and maintaining the equipment with a minimum of downtime.
- Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs, P&IDs and operations/maintenance procedures for facilities, utilities and process equipment.
- Responsible for the implementation of process improvements and corrective actions as well as the development of maintenance strategies and equipment life cycle.
- Responsible to support equipment IQ/OQ/PQ or any other validation startup activity as required.
- Responsible for equipment/facilities reliability improvements.
- Communicate efficiently with Contractors, Suppliers, OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.
- Able to work with other contractors, manufacturing, validations and quality control personnel regarding changes or improvements to the systems.
- Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate.
- Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures.
- Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications.
- Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities.
- Maintain a positive, professional, and customer oriented attitude.
- All other duties as assigned.
Required Skills & Abilities:
- Able to identify potential problem areas of equipment that is malfunctioning, using technical manuals or mechanical, electrical or controls knowledge.
- Knowledge and understanding using P&IDs, equipment manuals, specifications, SOPs, and be able to use proper judgment when taking corrective actions during equipment malfunctions.
- Strong analytical and problem solving skills. Possess or have the ability to apply these skills to resolve technical problems and to gain knowledge with respect to the operation and maintenance of various utility/process systems.
- Must be able to develop, and draft operational procedures and maintenance procedures for technical (utilities/process) equipment using the OEM manual and system knowledge.
- Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements.
- Must be able to use project management software such as Microsoft Project. Proficient with MS Office products (Word, Excel, Outlook, PowerPoint).
- Strong written and verbal communications skills, be self-motivated and possess interpersonal skills.
- Ability to learn quickly and work effectively with little supervision when needed.
- Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
- Knowledge of bio-medical, bio-technical equipment, both upstream and downstream highly desirable.
- All other duties as assigned.
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 require On-Call and/or off shift support/response for maintenance issues.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is Mandatory
- Bachelor's Degree preferably in Engineering such as Electrical, Chemical, Mechanical or Biomedical with two (2) years of experience in engineering and maintenance in an FDA regulated research or manufacturing facility; OR
- Associate's Degree preferably in Engineering such as Electrical, Chemical, Mechanical or Biomedical with four (4) years of experience in engineering and maintenance in an FDA regulated research or manufacturing facility; OR
- High School Diploma with at least one year of education or training in a college or university plus six (6) years of relevant engineering work experience in a bio-pharma research, manufacturing facility or related industry with the above listed equipment.