Engineering - Sr. Process Engineer

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

Job summary

An innovative firm is seeking a Senior Process Engineer to oversee engineering activities and enhance efficiency in biopharma manufacturing. This role involves collaborating with cross-functional teams to drive process improvements, manage equipment installations, and ensure compliance with regulatory standards. The ideal candidate will leverage their technical expertise to identify opportunities for innovation, support new product introductions, and maintain effective communication with stakeholders. Join a dynamic team dedicated to making a real difference in healthcare by contributing to the development of vital therapies and vaccines in a supportive and growth-oriented environment.

Benefits

Health insurance

Retirement plan

Flexible work hours

Professional development opportunities

Paid time off

Employee assistance program

Wellness programs

Tuition reimbursement

Qualifications

• 6-10 years of experience in pharma/biotech engineering.
• Expertise in equipment validation and compliance with FDA regulations.

Responsibilities

• Lead installations and process improvements for biopharma equipment.
• Support new product introductions and equipment commissioning.

Skills

Engineering and troubleshooting support

Problem identification and solution development

Project management

Process optimization

Equipment expertise

Collaborative/coordination skills

Validation and compliance

Effective communication

Regulatory and industry knowledge

Continuous improvement and learning

Leadership and professionalism

Results orientation

Adaptability and self-motivation

Safety focus

Education

Bachelor's degree in engineering

Master's degree in engineering

Tools

Project management software

MS Office

Job description

Position Overview

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 teams—facilities, manufacturing, CAPEX, validation, QA/QC, and contractors—for 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.

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 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, cross-functional 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 cross-functionally 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 problem-solving skills.
• Leadership and Professionalism: Demonstrating leadership, maintaining a positive approach, and managing multiple priorities efficiently.
• Results Orientation: Being goal-focused with strong analytical and risk management abilities.
• Software Proficiency: Proficient in project management software and MS Office.
• Adaptability and Self-motivation: Thriving in a fast-paced 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 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 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:

• Bachelor’s 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
• Master’s 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 bio-processing equipment, clean utilities, and single use equipment
• Knowledge of quality management software specifically Trackwise
• Engineering degree preferably in Mechanical, Chemical, Electrical or Biomedical Engineering

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]).