The Sr. Process Engineer, under the supervision of the Director of Engineering, will be responsible for performing engineering activities, new equipment/systems installation, new products introduction support, infrastructure assessments, troubleshooting support and technical expertise for process equipment and site utilities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support includes bioreactors, 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/water boilers, water purification and distillation units, wastewater treatment systems, among others. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC and contractors to perform projects implementation and to help maintain complex process equipment and site utilities. 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, SOP's development and equipment commissioning/qualification activities as required. This position will also lead the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.
- Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed.
- Proactively identify engineering problems or opportunities and apply technical expertise to develop and present feasible solutions.
- Lead and manage new equipment/systems installation including infrastructure, connectivity and capacity assessments.
- Lead and manage process improvements, corrective and preventive actions (CAPAs) and change controls implementation for process equipment and site utilities.
- Lead the identification of new equipment including but not limited to proper type, size, materials of construction, throughput, operational conditions, physical dimensions, required utilities, waste requirements, user requirements specifications (URS) and others.
- Support new product introductions (NPIs).
- Work with process sciences in developing new equipment/systems/process design, controls, requirements, specifications and drawings.
- Liaison with CAPEX team for the implementation of capital projects.
- Coordinate execution of projects, improvements and other engineering activities.
- Oversee contractors when implementation and/or corrections are required.
- Works with QA/QC to ensure proper testing, inspection and release after completion of engineering activities.
- Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
- Ensure new equipment operates in compliance with required EHS, regulations and codes.
- Develop, write, edit and/or review in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems.
- 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.
- Demonstrate leadership, technical aptitude, and problem-solving skills.
- Must be flexible and able to manage multiple priorities and tasks.
- Must be results driven and goal oriented with the ability to manage risks.
- Knowledge and understanding using P&IDs, equipment manuals, specifications, SOPs, and be able to use proper judgment when implementing projects or taking corrective actions during equipment malfunctioning.
- 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).
- Knowledge of regulatory requirements for manufacturing of pharmaceutical products.
- Strong written and verbal communications skills with the ability to effectively communicate within cross-functional teams and to upper management.
- Ability to organize and present technical overviews to engineering staff, cross functional departments, and upper management.
- Be self-starter, self-motivated, detail oriented 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 off shifts, weekends and/or holidays support.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is Mandatory
- Bachelor's Degree preferably in Electrical, Chemical, Mechanical or Biomedical Engineering
- Ten (10) years of qualified experience in an engineering role in an FDA regulated research or manufacturing facility
- Knowledge of bio-processing equipment, clean utilities, and single use equipment
- Knowledge of quality management software specifically Trackwise
Salary Starting salary will be commensurate with education and experience.
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 979-431-3500.