Engineering - Sr. Process Engineer

Summary: Reporting to the Director of Engineering the Sr. Process Engineer at Fujifilm Diosynth Biotechnology Texas (FDBT) oversees engineering activities including equipment installation and product introduction support infrastructure assessments and troubleshooting for process equipment and site utilities. The role involves supporting a range of equipment such as bioreactors incubators filtrations systems and others. The engineer collaborates with various teamsfacilities manufacturing CAPEX validation QA/QC and contractorsfor project implementation and equipment maintenance. Key responsibilities include driving process improvements via Change Control procedures and CAPA systems supporting P&ID maintenance strategy SOP development and equipment commissioning/qualification. Additionally they lead equipment selection sizing material specification utility needs and URS development for future projects.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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.

Essential Functions:

• Provide subject matter expert 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.
• Engage in ongoing assessment of processes for potential improvements and innovation opportunities to enhance efficiency and effectiveness.
• Facilitate effective communication and reporting to upper management crossfunctional teams and stakeholders to ensure alignment on project goals and status.
• 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.
• Oversee contractors when implementation and/or corrections are required.
• Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
• Develop write edit and/or review in collaboration with Facilities SOPs P&IDs and maintenance procedures for new equipment and/or systems.
• All other duties as assigned.

Required Skills & Abilities:

• Technical Expertise: Providing engineering and troubleshooting support.
• Problem Identification and Solution Development: Spotting engineering issues and crafting solutions.
• Project Management: Leading installations and process improvements.
• Process Optimization: Implementing upgrades and corrective actions.
• Equipment Expertise: Select and specify equipment types and specifications and ensure it operates in compliance with regulations and codes.
• Collaborative/Coordination Skills: Working crossfunctionally with teams like CAPEX and QA/QC. Coordinate execution of projects improvements and other engineering activities.
• Validation and Compliance: Assisting in equipment validation activities and adhering to environmental health and safety guidelines.
• Documentation and Procedures: Crafting SOPs P&IDs and maintenance protocols.
• Effective Communication: Coordinating with diverse stakeholders effectively including presenting technical overviews.
• Regulatory and Industry Knowledge: Understanding regulatory requirements and pharmaceutical manufacturing guidelines.
• Continuous Improvement and Learning: Keeping updated with SOPs and enhancing technical and problemsolving skills.
• Leadership and Professionalism: Demonstrating leadership maintaining a positive approach and managing multiple priorities efficiently.
• Results Orientation: Being goalfocused with strong analytical and risk management abilities.
• Software Proficiency: Proficient in project management software and MS Office.
• Adaptability and Selfmotivation: Thriving in a fastpaced environment learning swiftly and working independently.
• Safety: A focus on safety and compliance with regulations at the forefront of all activities.

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 handeye 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 PPE as required.
• The ability to regularly lift and/or move up to 50 pounds.
• Climb ladders and stairs of various heights.
• Be exposed to outdoor weather wet or humid conditions and/or noisy environments.
• This position may require off shifts weekends and/or holidays support.
• Attendance is mandatory.

Minimum Qualifications:

• Bachelors degree in engineering with six (6) to ten (10) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent preferably regulated by FDA or any other regulatory agency Or
• Masters degree in engineering with five (5) to eight (8) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent preferably regulated by FDA or any other regulatory agency.

Preferred Qualifications:

• Knowledge of bioprocessing equipment clean utilities and single use equipment
• Knowledge of quality management software specifically Trackwise
• Engineering degree preferably in Mechanical Chemical Electrical or Biomedical Engineering

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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or (979)).