Job Information
Fujifilm Process Sciences Sr. Engineer in College Station, Texas
Overview
TheSenior Engineerfunctionsindependently and productivelywithin ateam basedorganizationtoactivelyaddresscomplexcGMP manufacturing issues. The individualis responsible foranalyzing process technologiesinsupportofnew projectproposalsandtakes responsibility forthetechnical transferinto the manufacturing groupforClinicaland/or Commercial.This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in aCMO environment.
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:
Applies scientific andcGMP manufacturingexpertisetoresearch and resolveissues inthe technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.
Leadsmultiple overlappingcross-functionaltechnology transferteamsthat includeclient technical staff and internal process development and manufacturing teams.Will alsobe responsible forassistingother teams as SME.
Research and recommendsingle-useprocess equipment ofappropriate scaleand quality for thecGMPexecution of client specified manufacturing processes.
Responsible forthe preparation of user requirements, vendor quotes, and purchasing of equipmentas well as supporting capital projects by providing technical expertise.
Oversees and leads small complex engineering projects.
Assistin overseeing contractor activities, asrequired.
Provides technical information forthe preparation of change controls, protocols, and new user training for the process equipment.
ReviewsprocessrequirementsforGMP manufacturing throughprocess specificationsand batch records.
Identifiesraw materials and consumablesofappropriate qualityfor thecGMP execution of client specified manufacturing processes;assistsin the preparation of material specifications, vendor quotes, and the purchase of the materials.
Responds to clientand/or internal staff questions or concerns aboutcGMP equipment, materials, and procedures.
Useskey and critical process parameters and their associated critical quality attributes to assist in the preparation of product specifications.
Provides data analysisfrom each manufacturing runthat will be included in intermediate and final project summary reports and other team deliverables.
Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.
Perform all other duties as assigned.
Required Knowledge /Technical Expertise
Individual will haveknowledge/expertiserelevant to:
supporting single-use equipment and systems such as:
Fermentation and Cell Culture reactors
GE AKTA chromatography systems supported by Unicorn software
Tangential Flow Filtration Systems
Depth Filtration systems
Working withincGMPenvironmentsin relation to biologics and vaccine manufacturing.
Process development or manufacturing experience with clinical scale projects.
Single-use manufacturing equipment and materials.
Understanding and experience inaseptic techniques.
Document writing including protocols, batch records, and SOPs and summary reports.
UsingMicrosoft Excel, Word, and PowerPoint.
Other Abilities:
Process Validation(PCPV)skillsandexperience withstrategydevelopmentand authoringof deliverables(e.g.Process Control Strategy, Process ValidationMasterPlan(PVMP),PPQRun protocols, Ancillary Protocols, Continued Process Verification (CPV))
Demonstratedcredibility by performing high quality work.
Coaching and mentoring less experienced team members.
Expand the technical capabilitiesof teams usingacademic and hands-on experience.
Effectively communicates results of own work through meetings, presentations,discussionsand documentation with some input from supervisor.
Minimum supervisionrequiredon day-to-day activities and accomplished tasks.
Abilityto work inateam orientedenvironment is essential, as this person will work closely with otherteammembers andclients.
Self-motivated and capable ofdemonstratingtechnical competence.
Excellent interpersonal communicationskillsand ability to influence and collaborate in a team environment.
Analytical and excellent problem-solving skills.
Working Conditions & Physical Requirements :
The physical demands described here are representative of those that must be met by an employee to successfully perform theessential 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 employeeis regularly required to:
Experience prolonged standing,along withsome bending, stooping, and stretching.
Use hand-eye coordination and manual dexterity sufficient tooperatea keyboard, photocopier, telephone, calculator,and other office equipment.
Ability tolift upto 20 pounds regularly and up to 50 pounds on occasion.
Potential for exposure to hazardous chemicals, gases, fumes, odors,mists, anddusts, and other hazardous materials.
Ability to wear personal protective equipment to include safety glasses, lab coat, gloves or other equipment asrequired.
Attendance is mandatory.
Minimum Qualifications:
PhD with 1 year of relevant experience; OR
Master’s Degreewith 6yearsof relevant experience; OR
Bachelor’s Degreewith 8yearsof relevant experience; OR
Associate’s Degreewith10yearsof relevant experience.
Preferred Qualifications:
Experience in a GMP environment.
Degree in Engineering, Chemistry, Biology, LifeSciencesor related field.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to 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 (FDBTHR@fujifilm.com or (979) 431-3500).
Job Locations US-TX-College Station
Posted Date 4 days ago (1/20/2025 10:18 AM)
Requisition ID 2025-33090
Category Process Sciences
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies