Engineering - Process Engineer II

FUJIFILM Holdings America Corporation; College Station (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a talented Process Engineer II to join their innovative team. This role involves providing engineering support for complex process equipment and site utilities, leading new installations, and driving process improvements. You'll collaborate with various teams to ensure compliance with regulatory standards while enhancing operational efficiency. If you're passionate about making a difference in the biotechnology field and thrive in a dynamic environment, this opportunity is perfect for you. Join a company that values your expertise and offers a vibrant workplace culture in the heart of Texas.

Qualifications

• 2-6 years of engineering experience in a regulated industry.
• Bachelor's or Master's degree in Engineering required.

Responsibilities

• Provide engineering support for process equipment and site utilities.
• Lead new equipment installation and process improvements.
• Coordinate projects and oversee contractors.

Skills

Analytical Skills

Problem-Solving

Project Management

Technical Writing

Leadership

Communication

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Microsoft Project

MS Office Suite

Quality Management Software (Trackwise)

Job description

Position Overview

Summary : The Process Engineer II, 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.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

Essential Functions:

• 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.
• All other duties as assigned.

Required Skills & Abilities:

• Strong analytical and problem-solving skills. Able to identify potential problem areas of equipment that is malfunctioning, using technical manuals or mechanical, electrical or controls knowledge.
• Demonstrate leadership, technical aptitude, problem-solving skills, and a continuous personal pursuit to increase job knowledge, proficiency in technical understanding, and problem-solving abilities and knowledge of pharmaceutical/biotechnology regulatory requirements.
• Flexible and able to manage multiple priorities and tasks.
• Results driven and goal oriented with the ability to manage risks.
• Ability to develop, write, edit and/or review in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems and stay current with training.
• 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.
• 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.
• Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications.
• Maintain a positive, professional, and customer-oriented attitude.
• 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).
• 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, research and customized manufacturing facility.
• Knowledge of bio-medical, bio-technical equipment, both upstream and downstream highly desirable.

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.
• Ability to wear required PPE.
• The ability to regularly lift and/or move up to 50 pounds and 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 and noisy environments.
• Attendance is Mandatory

Minimum Qualifications:

• Bachelor's degree in engineering and a minimum of two (2) to six (6) years of qualified experience in an engineering role in a highly regulated industry; OR
• Master's degree in engineering and a minimum of two (2) to five (5) years of qualified experience in an engineering role in a highly regulated industry.

Preferred Qualifications:

• Degree preferably in Mechanical, Chemical, Electrical or Biomedical Engineering
• Preferable experience in a pharma/biotech manufacturing facility or equivalent experience regulated by the FDA or other regulatory agency.
• Knowledge of bio-processing equipment, clean utilities, and single use equipment
• Knowledge of quality management software specifically Trackwise.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).