FUJIFILM Medical Systems USA jobs in College Station, TX

The Associate Director Human Resources is responsible to lead the strategic execution to of human resources in order to meet the business needs of the site. This position reports to the Head of People & Culture and participates with the extended executive leadership team in developing and implementing company policies and procedures. Provides guidance and leadership to management and employees on Human Resources matters. The Associate Director, Human Resources executes in all areas of Human Resources services, including policies and programs for the entire site. Job Description Essential Functions: Build effective relationships with business leaders, internal support teams, and other key stakeholders to enable effective implementation of HR plans and programs, while ensuring programs are aligned with overall business strategy and goals. Coaching, counseling and guidance regarding complex employment issues. Implement, monitor and audit compliance to regulatory concerns and ensure proper documentation and reporting occur; Facilitate organization development to include staffing structure, position descriptions, organizational charts, succession plans, etc.; Provide leadership and expertise in developing, recommending, and implementing compensation programs including market pricing and analyzing compensation practices for internal equity. Manage and lead recruitment and retention efforts to continuously improve recruiting processes to attract and retain qualified diverse candidates; Maintain performance management and improvement systems; Support the development, implementation and monitor policy development and documentation; Responsible for investigating and recommending solutions to employee relations concerns and issues; Oversee payroll processing to ensure accurate pay practices; Coordinate employee and community communication and activities; Partner with Employee Health and Safety team to ensure employee safety, in addition to the welfare, wellness and health of employees; Manage charitable giving and company participation; Ensure employee assistance services and counseling services are available to all employees. All other duties as may be assigned Required Skills & Abilities: Must be a collaborative business partner Must be proficient with standard office equipment and software (e.g., Microsoft Word, Excel, PowerPoint and other HR specific software applications). Excellent organizational skills. Detail oriented and accurate. Demonstrated ability to multi-task and prioritize work assignments with little supervision. Working knowledge of federal and state employment law. Problem solving skills. Must read, write and speak clearly. Professional appearance, attitude, demeanor. Customer service orientation. Creative approach to recruiting and retention. 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 a keyboard, photocopier, telephone, calculator, and other office equipment is required. Minimum Q u a li f i c a tions: Bachelor Degree preferably in Human Resources, Business Management, or a related field and 8 years of related experience of which 4 years must be in a management role or Master's degree and 6 years of experience in a similar role of which 4 years must be in a management role. Demonstrated experience mentoring leaders (Managers/Supervisors) Experienced working in a changing, project driven organization Preferred Q u a li f i c a tions: PHR and/or SPHR Certifications.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FUJIFILM Biotechnologies, Texas. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FUJIFILM Biotechnologies, Texas Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks. Reports to Senior Director, QA Compliance Work Location College Station, TX Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Primary Responsibilities: Work collaboratively with all levels of the FUJIFILM Biotechnologies, Texas site to instill a ‘Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. Act as an ambassador for FUJIFILM Biotechnologies, Texas Quality Culture. Deputize fronting Data Integrity in customer and regulatory audits (as required). Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products. Work as a change agent to compliantly improve existing or introduce new ways of working. Strong experience with GMP, manufacturing processes, quality and regulatory requirements. Ensure smooth operation of the FUJIFILM Biotechnoloigies, Texas Data Integrity program highlighting any issues in a timely manner. Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed. Provide coaching and training for staff in Data Integrity Principles. Engage in global FUJIFILM Biotechnologies projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems. Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up. Review pre-purchase of systems and analyze to ensure Data Integrity Compliance. Draft FMEAs and lead stakeholder meetings. Raise and manage change controls and CAPAs, and drive mitigation and remediation. All other duties as assigned. Qualifications: Bachelor's degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products or 1 year experience with FUJIFILM Biotechnologies with a related role; OR, Associate's degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR; High School or equivalent and 6+ years of experience of cGMP supporting pharmaceutical or biotechnology products. Involvement in Data Integrity projects during previous roles preferred. Ability to collaborate effectively with stakeholders from across the business, at all levels. Excellent written and oral communication skills. Excellent organizational, analytical, data review and report writing skills. Motivated cross functional worker. Ability to set and achieve personal performance goals. Provide input to departmental objectives. Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.Develop staff to maximize contributions to the team and the company. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Proficient in Microsoft Excel, Word and PowerPoint. All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. Role model for company core values of trust, delighting our customers, and Genki. 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 standing, some bending, stooping, and stretching. Ability to sit for long periods to work on a computer. Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials. Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position. Lifting up to 25 pounds on occasion. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Must be willing to work flexible hours. Ability to work weekends and off-shift hours, as needed to support manufacturing activities. Must be willing to travel occasionally, as needed. Attendance is mandatory. 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 (******************* or ***************.

The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following: **Company Overview** The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** **Job Description** **Upstream Unit:** + Single-Use Cell Culture Vessels/Bioreactors up to 2000L + Bacterial Fermentation Culture Vessels up to 2000L + Alpha Wasserman Continuous Flow Centrifuges + Disposable Magnetic Mixing Bags and Totes + Cell Expansion and Propagation + Banking/Cryopreservation of Cell Lines and Viruses + Hyperstack, Cellstack, and other Adherent Cell Technologies + Plate counting, microscopic examination + Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation **Downstream Unit:** + Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration + Medium to Large-scale Chromatographic systems (ÄKTA). + Pre-Packed Columns from 1L to 100L + Single use mixing systems (Pall & GE) + Single Use connectivity types such as GE DAC and Colder AseptiQuik + Bulk filling + Aseptic process simulation and drug product filling + Plate counting, microscopic examination + Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation **Buffer Preparation Unit:** + Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs + Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs + Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures + Integrity testing of filters **_Essential Functions Include:_** + Write and review standard operating procedures, buffer formulation records and batch production records. + Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs. + Maintain the confidentiality of proprietary company information. + Document and maintain activity records according to cGMP regulations and ensure junior team members are trained. + Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc. + Perform all other duties as assigned. **Technician IV - Supervisory Track Option:** + Successfully leads two or more projects at a time. **_Required Skills & Abilities:_** + Excellent oral and written communication skills, interpersonal and organizational skills. + Proficient with Microsoft Office applications. + Excellent leadership skills. + Ability to train others to perform to cGMP standards. + Good self-discipline and attention to detail. + Must be able to work flexible shifts to include weekend or night shifts, and be willing to work outside of normal scheduled hours to meet the demands of the business. + Excellent math and computer skills. + Experience working in a cleanroom environment with full clean room gowning and good aseptic technique. + Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities. **_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 standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching. + Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. + Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. + Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves. + Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally. + Attendance is mandatory. **_Technician IV Minimum Qualifications:_** + Bachelors degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; OR + Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; OR + High School/GED with 6 years of relevant experience. **Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.** _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 (******************* or ***************. **Job Locations** _US-TX-College Station_ **Posted Date** _3 weeks ago_ _(11/20/2025 11:38 AM)_ **_Requisition ID_** _2025-36196_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Upstream Unit: Single-Use Cell Culture Vessels/Bioreactors up to 2000L Bacterial Fermentation Culture Vessels up to 2000L Alpha Wasserman Continuous Flow Centrifuges Disposable Magnetic Mixing Bags and Totes Cell Expansion and Propagation Banking/Cryopreservation of Cell Lines and Viruses Hyperstack, Cellstack, and other Adherent Cell Technologies Plate counting, microscopic examination Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Downstream Unit: Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration Medium to Large-scale Chromatographic systems (ÄKTA). Pre-Packed Columns from 1L to 100L Single use mixing systems (Pall & GE) Single Use connectivity types such as GE DAC and Colder AseptiQuik Bulk filling Aseptic process simulation and drug product filling Plate counting, microscopic examination Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation Buffer Preparation Unit: Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures Integrity testing of filters Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures Integrity testing of filters Required Skills & Abilities: Good oral and written communication skills, interpersonal and organizational skills. Strong proficiency with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours - must be willing to work outside of normal scheduled hours as necessary including opportunities for overtime. Good math and computer skills. Must possess good planning and time-management skills and be willing and able to interface with colleagues in various roles and functions throughout the manufacturing facilities. 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 standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Use of hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment. Lift up to 25 pounds frequently and up to 50 pounds occasionally. Attendance is mandatory. Minimum Qualifications: Associates degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR High School Diploma/GED with 1 year of work experience. Preferred Qualifications: Experience in a GMP environment Biotechnology Certificate 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 (******************* or ***************.

The Associate Director of Communications in Texas will spearhead communication strategy, planning, and content development, supporting the local Site Head and the Leadership Team. The role is pivotal in establishing thought leadership, nurturing internal culture, and enhancing our external reputation via effective stakeholder and media relations and dynamic social media engagement. Strong collaboration with regional offices and the global corporate affairs team is essential. The role aims to improve trust and motivation within the organization and ensure a comprehensive communications plan that reflects both local and global priorities. Job Description Essential Functions: Strategic communication and planning: Design and implement integrated communications strategies that align with business objectives and reflect both local and global priorities. Enhance the company's overall reputation within Texas, the United States, and globally, fostering organizational trust and motivation. Content development for internal and external channels. Oversee creation of compelling content, including press releases, reports, blogs, and internal communications. Lead storytelling initiatives that drive engagement locally and globally and align with our brand values. Stakeholder and Media Relations: Cultivate and manage relationships with local leaders and key media outlets. Develop press materials and respond to media inquiries to maximize positive coverage of the company's activities. Thought leadership. Support leadership in establishing a strong voice within the industry at local level but with global impact. Identify opportunities for speaking engagements and authored articles. Together with the corporate team elevate our social media presence with innovative strategies that resonate with diverse stakeholders. Monitor and analyze social media metrics to enhance engagement. Employee Communication and Events: Drive communication programs that bolster employee engagement and internal culture. Work closely with HR and senior leadership to ensure alignment. Implement initiatives aimed at increasing organizational trust and employee motivation. Plan and execute internal events that support cultural engagement and align with our communication initiatives. Host events that inspire and motivate employees, reinforcing trust within teams. Collaborative Engagement: Build strong relationships locally to support creating strong communication approaches and campaigns. Partner with regional offices and the global corporate affairs teams to ensure cohesive messaging across all platforms. Facilitate cross-functional collaboration to support communication initiatives. Required Skills & Abilities: Proven experience in a senior communication role, ideally within pharma or CDMO. Strong track record of successful media and public relations initiatives. Exceptional writing and verbal communication skills, with the ability to convey complex information clearly. Demonstrated experience in strategic planning and executing multi-channel communication campaigns. Ability to develop and implement communication plans that reflect local and global priorities. Proficiency in digital communications, including social media strategy and content management. Ability to thrive in a fast-paced environment, managing multiple initiatives under tight deadlines. Excellent interpersonal skills, with the ability to influence at all organizational levels. Strong analytical skills to assess the effectiveness of communication efforts through quantitative and qualitative means. Bachelor's degree in Communications, Public Relations, Journalism, or equivalent experience. 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, some bending, stooping and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Onsite attendance needed for a minimum of 3 days per week. Minimum Qualifications: Master's degree in Communications, Public Relations, Journalism, or equivalent and 8-10 years of relevant communications experience; OR Bachelor's degree in Communications, Public Relations, Journalism, or equivalent experience and at least 10-12 years of relevant communications experience. 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.

The Quality Control Project Coordinator III will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities. The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing. The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities. The coordinator will assist the QC Analyst's and QC Management to navigate GMP documents through the EQMS system. Close attention to detail is required to update the Master Schedule daily to ensure QC deadlines and milestones are met. Other responsibilities may include but are not limited to: Compiling data for Batch Disposition. Attending planning meetings as needed. Communicating gaps and schedule changes to QC Area Managers. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description If you are a current FUJIFILM Employee, please follow this link to apply via our Internal Career Portal: FUJIFILM Internal Careers Page Reports to QC Project Coordinator Supervisor, QC Manager, or Director of QC Work Location College Station, TX Essential Functions: Follow Standard Operating Procedures (SOP's), other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP), and other site procedure documents (such as Chemical Hygiene Plan, SDS sheets). Construct and maintain a QC Master Schedule, Assists in preparing QC metrics monthly. Alignment of QC Master Schedule to projected manufacturing schedules. Assist in generating POs for external testing. Work directly with Contract laboratories to coordinate and monitor testing per timelines. Work directly with customers to update and confirm schedules and deadlines. Attend daily briefings and update as needed. Lead team and department meetings. Assist QC Director and QC Managers to oversee and coordinate departmental training. Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish timelines. Work with customer and other appropriate parties to establish GMP documents. Provide technical suggestions to customers based on industry guidelines. Follow all established laboratory, regulatory, safety, and environmental procedures. Perform other duties as assigned. Required Skills & Abilities: Must be highly organized, driven, and possess the skills and capability to plan ahead and stay on schedule. Ability to evolve and adapt to new technologies to include electronic planning tools and Laboratory Information Management Systems (LIMS) Computer skills in Microsoft Office and Microsoft Project Ability to multi-task and prioritize work assignments with little supervision. Excellent attention to detail. Ability to work in a team or independent setting and collaborate with employees from various departments. Excellent analytical and planning skills. Must have excellent organizational, written and oral communication skills. Role model for company core values of trust, delighting our customers, and Gemba. 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 standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Attendance is mandatory. Minimum Qualifications: Master's degree and 1+ year in GxP setting and with a combined total of 2 years between coordinator/management position and GxP experience (or equivalent). Bachelor's degree and 2+ years in GxP setting with a combined total of 4 years between coordinator/management position and GxP experience (or equivalent). Associates degree and 2+ years in GxP setting and a total of 6 years between coordinator/management position or GxP experience (or equivalent). High school or GED and 2+ years in GxP setting and a total of 8 years between coordinator/management position and GxP experience (or equivalent). Preferred Qualifications: Degree in a scientific discipline. GMP/GLP experience. PMP Certificate. Analytical background. Client relations background, and/or Customer interaction training. Salary: Starting salary will be commensurate with education and experience. 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 (******************* or ***************.

We are seeking a progressive HR Business Leader and a trusted strategic business partner to the Senior Leadership Team in College Station, Texas to provide strategic direction and expertise for the Human Resources function. You will be responsible for building, planning, developing, implementing, and directing policies and programs, including strategic planning, organizational design, employee relations, equal employment opportunity, performance management, employment law, and compliance. At FUJIFILM Biotechnologies, we encourage you to discover what inspires you every day, to follow your passion and your power - what we 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 As our Head of People & Culture (Senior Director) for our Texas facility, and reporting into the Site Head, with a dotted line to the Chief People Officer, you will be responsible for driving and supporting a positive culture by sponsoring teams that focus on employee engagement programs, efforts, and activities for the site. You will drive and facilitate cultural and organizational development initiatives that foster a positive and high-performance culture including employee engagement. You will be responsible to the Head of the Site for the effective and efficient utilization of workforce for the Company. You will partner with the Head of the Site and the senior leadership team to deliver thought leadership regarding organizational and people-related strategies and execution as well as to provide insightful data to guide decision-making and proactive solutions. The ideal candidate has a demonstrated track record of successfully managing end to end People & Culture practices across talent acquisition, performance management, human resource management, workforce planning, communications, and external relations, The successful candidate will have experience effectively coaching, guiding, and influencing leadership to drive a dynamic, inclusive culture and environment of the company. Ideally, the candidate has experience both from working in a ramp up environment, but also from working in a large global matrix organized company, to be able to navigate in both complexities. Key Responsibilities: This position requires a visionary leader capable of integrating global HR strategies into local execution, actively supporting business growth, and enhancing cultural and employee experiences at the manufacturing site. The role demands strategic collaboration with global CoEs to drive transformation and ensure seamless alignment in Compensation & Benefits, Leadership Development, and Talent Attraction. Strategy Development & Alignment: Develop a site P&C strategy/action plan that aligns with business and the global P&C strategy Drive selected initiatives in the site strategy especially within culture, engagement and organizational effectiveness Collaborate with CoEs to create the P&C platform of the future and at the same time ensuring the local execution of both global and local P&C initiatives Transformation & Business Integration: Drive the transformation of P&C functions from transactional roles to more strategic business partners, enhancing alignment with global business strategies Embed strategic HR initiatives into daily business operations, fostering synergy between HR and other business units Drive structured Organizational design and review processes for the site Advanced Workforce Planning: Together with Finance and CoE for TA drive the development of a solid strategic workforce plan that align with business goals and facilitate attraction, recruitment, and retention of top talent Analyze workforce data to ensure optimal alignment with business priorities and future growth opportunities. Make P&C a strong partner in developing the site in the best way possible. Talent Management & Leadership Development: Work closely with the Leadership Development CoE to design and execute programs that build leadership capabilities aligned with business strategy Develop retention strategies for key critical people Compensation & Benefits Strategy: Collaborate with the Compensation & Benefits CoE to fully understand the compensation philosophy for Texas and make sure there is a solid and aligned plan for how to develop this Ensure compliance and alignment with global policies while adapting to local market needs. Revisit existing policies to make sure they are aligned with culture and are as flexible as possible to be able to adjust to changing business needs Drive the local implementation of Performance management of the future and “We talk we grow” Cultural Transformation & Employee Engagement: Lead cultural transformation through a people first mindset and our People Fundamentals. This needs to build on the many cultural strengths of the site and at the same way challenge status quo Develop a clear and ambitious plan for how to increase engagement and at the same time align with business needs HR Analytics & Strategic Reporting: Drive a strong data foundation and utilize HR analytics to provide strategic insights, supporting informed decision-making that aligns with business strategies Communicate P&C's impact on business metrics through robust reporting systems, highlighting successes and areas for improvement Manages Assigned P&L Budget Responsible for creating and maintaining the site's annual People and Culture budget with an eye toward optimizing cost while balancing risk and building culture. Governance & Compliance Strategy: Ensure strategic oversight of compliance within P&C initiatives, aligning with local and global legal standards and industry best practices Collaborate with global teams to ensure policy implementation supports business objectives and ethical standards Qualifications & Experience: Bachelor's degree in Human Resources, Business Administration, or related field; Master's preferred 15 + years experience within Human Resources 10+ years' experience managing, leading and developing people Proven experience in strategic HR leadership roles within a manufacturing or pharmaceutical environment, with emphasis on collaborating with global teams. Experience developing a P&C strategy as well as experience in business transformation Strong analytical skills and can demonstrate experience from creating results through data driven P&C Excellent interpersonal and leadership skills, with the ability to influence and implement change across all levels of the organization Demonstrated experience in creating excellent results through people and visionary direction setting Join us! Fujifilm Biotechnologies is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large. 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 email ******************* or call ************. 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.

The Regulatory Affairs Specialist II is responsible for supporting the Regulatory Intelligence deliverables, the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Biotechnologies partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format and working with site functional groups with their response to changes in relevant Regulatory Intelligence. Actual work assignments are based on the FUJIFILM Biotechnologies portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's development plan. The Regulatory Affairs function supports all FUJIFILM Biotechnologies Texas - related regulatory affairs activities for FUJIFILM Biotechnologies partner companies' products, summarize regulatory intelligence, provides regulatory-compliance input for regulatory submissions, and manages the FUJIFILM Biotechnologies Texas response to changes in the regulatory landscape. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to Director, Regulatory Affairs Work Location College Station, TX Primary Responsibilities: Obtain data/documents from multiple internal teams for exchange and/or communication with FUJIFILM Biotechnologies partner companies. Upload information to the Regulatory documentation management location for future use. May be required to compile and report key information to pertinent stakeholders within the Quality team to ensure proper visibility and communication. Support a vibrant regulatory culture, working among functional groups as a teammate and collaborator to develop successful regulatory strategies. Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured and/or distributed by FUJIFILM Biotechnologies partners. Support development teams working towards modifying existing processes or creating new processes; ensure compliance with existing design controls, risk management, and domestic and international regulations. Ensure timely approvals, communicate, and support negotiations with the FDA and other regulatory bodies as needed to identify pre-submission requirements and strategy and to resolve post-submission queries and issues. Maintain proficiency on regulatory requirements; and FDA/Notified Body published reviews as applicable. Provide continuing regulatory education and disseminate regulatory information to the product development, marketing, and clinical groups. Ensure that regulatory intelligence communications are disseminated in a timely manner to the appropriate business functions and appropriate actions are taken by the respective stakeholders. Be responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedures. May support the review and negotiation of Master Service Agreements (MSA) and Quality Agreements (QAg). Qualifications: Bachelor's degree from accredited university with 1+ year of GMP working experience. Associate degree from accredited university with 3+ years of GMP working experience. Working knowledge of Regulatory Information Systems, planning and /or publishing tools. Working knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines. Effective interpersonal, teamwork, networking, and communication skills. Proficiency in applying submission-readiness and publishing standards via Adobe Acrobat, MS Word and related applications. Proficiency with various aspects of the PQS, specifically Change Controls, CAPAs, Deviation Management. Demonstrated ability to build productive relationships across an organization and with FUJIFILM Biotechnologies partner companies is required. Problem-solving capability, including trouble shooting and adaptability required. Understanding of the drug development process. Skill to apply knowledge of submission-readiness and publishing standards. Cell & Gene Therapy area and product knowledge, strong understanding of product development process. Fluency in English, proofreading and strong negotiation skills. Ability to work or lead in a matrix environment. Ability to execute assignments independently as assigned. Must possess strong organization skills, strong written and verbal communication skills. Demonstrated ability to handle multiple competing priorities simultaneously. Role model for company core values of trust, delighting our customers, and Gemba. 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 essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, stooping, and stretching. Ability to sit for long periods to work on a computer. Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials. Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position. Lifting to 25 pounds on occasion. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Must be willing to work flexible hours. Ability to work weekends and off-shift hours, as needed to support manufacturing activities. Must be willing to travel occasionally, as needed. Attendance is mandatory. 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 (******************* or ***************.

: The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs. The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC. The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to Associate Director, QC Analytical Work Location College Station, TX Essential Functions: Desirable candidate will have a strong QC mindset and bringing Quality-by-Design concept (QbD) into analytical activities to ensure robust methods entering the QC space. Project management expertise for analytical activities (planning, timeline creation, team management, effective escalation, drive for success and on-time completion of activities). Technical expertise in several of the following fields, specifically in the analysis of proteins: plate-based assays (SoftMax Pro), Molecular Biology assays (qPCR, dd PCR), Cell based assays (e.g. Potency, Cytotoxicity, TCID50, BacPAK), H/UPLC (Empower), electrophoresis, spectroscopy, microbiology (bioburden, endotoxin), and Compendials including appearance, pH, osmolality. As a senior scientist, you must have demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques. Designing, managing, and executing protocols for the Qualification, Validation, Verification or assay Tech Transfer of recombinant biopharmaceutical protein analytical methods. Late-stage method validation experience is also highly desired. Managing a team of scientists in a direct or matrix environment with an eye towards team development with high performing scientists. Regulated GMP experience, with knowledge of ICH guidelines for methods, positive working relationships with Quality groups and experience with opening, executing and closing protocol events, investigations and change controls within Trackwise. Regulatory audit experience is a plus. Required Skills and Abilities: Must have the cell culture experience and bioassay design experience. Strong mentorship skills. Excellent work ethic with a strong emphasis on data integrity. Strong oral and written communication skills. Demonstrated ability to engage with clients. The optimal candidate will have a keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients. Continuous improvement initiatives (initiating and completing). Excellent interpersonal skills, the ability to work individually or as part of a team; a person who highly values collaboration. Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines. Role model for company core values of trust, delighting our customers, and Gemba. 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 standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position. Lift up to 30 pounds on occasion. Attendance is mandatory. Qualifications: PhD in the Biotechnology/Biopharmaceutical industry, or related field, and 1+ year of experience working in the Biotechnology/Biopharmaceutical industry; OR, Master of Science in the Biotechnology/Biopharmaceutical industry, or related field, and 6+ years of experience working in the Biotechnology/Biopharmaceutical industry; OR, Bachelor of Science in the Biotechnology/Biopharmaceutical industry, or related field, and 8+ years of experience working in the Biotechnology/Biopharmaceutical industry; OR, Associate of Science in the Biotechnology/Biopharmaceutical industry, or related field, and 10+ years of experience working in the Biotechnology/Biopharmaceutical industry. Preferred Qualifications: Experience working in or interfacing with a regulated GMP environment is desirable. Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to work with clients). 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 (******************* or ***************.

The CAD Specialist, guided by the Principal Engineering Manager-Engineering Projects, is tasked with enhancing the CAD function and defining the engineering document management strategy at the College Station site. Responsibilities include routine to moderately complex design and drafting for engineering, manufacturing, facilities, and validation. The role involves maintaining FDBT's engineering documents-including drawings, blueprints, P&IDs, and technical manuals-in both hard copy and electronic formats. Duties also encompass verifying and updating equipment and facilities documents in collaboration with contractors, engineers, and validation staff, managing changes through authorized engineering change control. This includes revising facilities, OEM, and vendor drawings, drafting preliminary changes, and tracking outdated or obsolete documents. Additionally, the CAD Specialist collaborates with engineers and equipment OEMs to ensure access to current versions of turnover. Job Description Essential Functions: · Fujifilm's Subject Matter Expert for CAD systems, software, processes, and procedures. · System owner for all drawing management software, e.g., Meridian, AutoCAD, Revit, etc. as required. · Create and/or update engineering drawings and supporting documentation adhering to FDBT CAD Standard, A/E Firm Project Standard, and/or local procedures. · Prepare complex drawings, layouts, designs, and/or technical illustrations using CAD/CAM technology or other methods as needed. · Perform field verification and collect as-built conditions to update system drawings. · Develop schematics for complex modifications to engineering systems and conceptual designs for new systems. · Ensure revision control of CAD files, retention, and format review of drawings. · Modify and track changes to systems using revision control. · Collaborate with vendors, engineers, and OEMs to obtain and update drawings through FDBT methods (e.g., change control). · Develop procedures, standards, job aids, URS, and best practices for CAD function and document management strategy. · Other duties as assigned. Required Skills & Abilities: · Understand symbols and icons used in P&IDs, blueprints, and architectural drawings. · Ensure compliance with internal quality protocols, SOPs, cGMP, and FDA guidelines. · Collaborate with engineers and validation contractors to ensure drawings are provided in an acceptable format. · Strong CAD skills and experience with programs like SolidWorks, Revit, etc. · Solid understanding of revision control and regulated document lifecycle. · Strong written, verbal, and interpersonal communication skills for documentation control and revision control procedures. · Desire to work in a fast-paced, state-of-the-art facility. · Ability to work independently and convince management through written and verbal methods. · Strong knowledge of MS Office products (Word, Excel, Outlook, PowerPoint). · Strong communication skills with maintenance trades (HVAC, Electrical, Mechanical, etc.). · Knowledge of Meridian Document Management software. · Leadership skills for decision-making under pressure and problem-solving. 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. · Don and doff needed PPE. · The ability to regularly lift and/or move up to 50 pounds. · Climb ladders and stairs of various heights. · Be exposed to wet, noisy, humid conditions and/or outdoor weather conditions. · Attendance is mandatory. · This position may require off shifts, weekends and/or holidays support. Qualifications: · Bachelor's degree with five to eight [5-8] years of CAD experience with; OR · Associates degree with six to ten [6-10] years CAD experience; OR · A minimum of four [4] years of qualified experience in an FDA or other regulated industry. Preferred Qualifications: · Degree preferably in Drafting, CAD Design, SolidWorks, and/or other engineering design programs of study or related field. · Knowledge of design and construction methods of bio-processing equipment, clean utilities, and other equipment. · Experience should include drawings and document management for clean utilities, architecture, and equipment · Experience with Meridian Document Management Software. 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.

Working as part of the Fujifilm Diosynth (FDB) Operational Excellence function, the Director, Project Management will lead project delivery lifecycle management process. The candidate will drive key organizational initiatives and large cross-functional projects and deliver tangible outcomes. The Director, Project Management will manage several projects (tech and non-tech) leveraging LSS, Agile or similar methods support organizations need of today, while preparing robust foundations for tomorrow. Additionally, the leader will possess excellent influencing, communication and collaboration skills with demonstrable experience in driving project from initiation, planning to completion, gathering and aligning business requirements, developing business case, assessing value, with the ability to identify & manage inter-dependencies. Candidate must be skilled in meeting engagement expectations, cross-functional stakeholders mgmt., and lead project team to influence and drive behaviors. The successful candidate will be data-driven, people management skills to drive optimal performance, skill development, and create high-performing teams. Job Description Essential Functions: Taking direction and aligning with the Head of Operational Excellence, to support the delivery of business-critical projects Following the ways of working to deliver projects on time, on budget and to specification Creating and delivering project work plans and adapting to meet changing needs Analyzing business needs, leading to clear and concise business case Developing a critical path/milestones of key activities, providing planning support and identifying and managingdependencies across the plans Developing team skills and creating high-performing teams Engaging stakeholders by sharing timely updates, pivoting to attend to dynamic business environment and partnering with the Head of Operational Excellence to manage risks/escalations Ensure project documents are complete, current, and appropriately stored. Track and report on project delivery and progress, and identify and manage dependencies, risks, and issues Negotiating trade-offs and brokering decisions to address dynamic situations Managing scope while building collaborative and high-performing teams through this change Required Skills & Abilities: The ideal candidate will have the following knowledge, skills and aptitude: Excellent written and verbal communication skills Ability to influence, negotiate and persuade, at all levels within the organization Ability to present complex information in a clear and concise manner Ability to coordinate activities across the project team Ability to effectively prioritize Ability to adjust personal style when dealing with different individuals Minimum Qualifications 10-12 years' experience successfully leading Operational Excellence, global projects, or cross-functional and high value projects Experience mentoring project team members Experience of using a wide range of project management tools and techniques consistent with lean, six sigma, and Agile methodologies Willingness to develop additional skills to support organizational goals Preferred qualifications Experience working within a Biotech/Pharma organization. Experience working within a Contract Development and Manufacturing Organization Black, or Master Black belt certification Experience delivering training PMP certification Experience with relevant project management software (MS Project, etc) 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.

The Document Control Specialist II has depth and specialized knowledge of cGMP documentation. This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training. Additionally, the individual who performs this role will have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements. They may be assigned duties representing Quality in appropriate situations as defined by their management. Job Description Reports to Senior Manager, Quality Assurance Compliance Work Location College Station, TX Essential Functions: Processes document routing request forms. Assigns document control numbers. Inputs training records and maintains official company training percentages. Provide draft documents as requested. Ensure documents are routed to appropriate individuals. Reviews and makes documents effective. Assigns effective dates to approved controlled SOPs, PRs, and policy documents. Notifies staff of all recently approved documents and identifies training requirements as necessary. Verifies and documents staff training has been completed as required. Archiving all company documents as necessary. Assembles, tracks and distributes, as appropriate, document requests made during site inspections by an inspecting Regulatory agency/representative. All other duties as assigned. Required Skills & Abilities: Excellent written and oral communication skills. Excellent organization. Experience with Word, Excel, and Adobe PDF. Role model for company core values of trust, delighting our customers, and Gemba. 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, some bending, stooping and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to access and utilize computer interfaces for extended periods of time. Attendance is mandatory. Qualifications: Bachelor's degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR, Associate's degree in a related science concentration with 4+ years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR, High School or equivalent with 6+ years or more of Pharmaceutical or other Regulated Industry experience. Preferred Qualifications: Experience with Quality Systems, i.e. Trackwise and Master Control 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.

The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory. The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to QC Manager, Chemistry Work Location College Station, TX Primary Responsibilities: Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments. Coordinate QC analytical testing for GMP release and stability testing. Ensure QC equipment is maintained in a qualified state. Prepare and execute tech transfer, qualification and validation protocols and reports as needed. Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation. Establish a system for managing test samples, reagents and reference standards. Review and approve data / reports during release & stability testing. Ensures laboratory compliance to established specifications and procedures. Reports excursion/out of specifications results and conducts investigations as needed. Assure the implementation of appropriate and timely corrective actions. Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team. Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support. Interface with current and potential clients as well as interface with investigators during internal and external inspections. Follow all established laboratory, regulatory, safety, and environmental procedures. Identify deviations and report possible preventative and corrective actions. Perform other duties as assigned. Required Skills & Abilities: Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies. Operate as a team leader, coordinate staff scheduling. Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Develop staff to maximize contributions to team and company. Ability to multi-task and prioritize work assignments with little supervision. Excellent attention to detail. Computer proficiency required. Ability to accurately review and complete required documentation. Excellent written and oral communication skills. Excellent organization and analytical skills. Role model for company core values of trust, delighting our customers, and Gemba. 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 standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Chemistry or Biochemistry with 3+ years of industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role; OR, Bachelor's degree preferably in Chemistry or Biochemistry with 5+ years industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role. Preferred Qualifications: Analytical laboratory experience in a GLP/GMP regulated environment is preferred. Experience in Trackwise Deviation Management software. Experience in Empower 3 software. 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 (******************* or ***************.

TheDirector of Facilities at Fujifilm Biotechnologies Texas (FLBT)is responsible foroverseeing a diverse team of facilities personnel. This role focuses on the operation of buildings,site services,metrology activities, and the maintenance of utilities, equipment, and biotechnology manufacturing facilities. Leadership responsibilities may extend to supervising the Security team.The ideal candidate will ensure the efficient and effective operation of all physical assets and infrastructure,maintaininga safe, functional, and welcoming environment for employees and visitors alike. **Job Description** **_Essential Functions:_** + Oversee overall building operations, includingmaintenance and metrology, site services,planning and scheduling, MRO, Security,andcompliancegroups. + Responsible forthe operation and maintenance offacility systems such asbut not limited to HVAC,RO/DIwater, WFI,CleanSteam,Clean Gases,Boilers, Chillers,Electrical,UPS,Back-UpPower,Waste,etc. + Overseehousekeeping, space planning, landscaping, and parking facilities tomaintaina clean and organized environment. + Manage relationships with external service providers to ensure high-quality maintenance and service delivery. + Develop and implement strategies for building operations, ensuringoptimalefficiency and functionality. + Ensuresproper operation of systems in compliance with required regulations and codes. + Conduct troubleshooting of facility infrastructure and production equipment. Implement and manage planned maintenance programsutilizinghistorical data andmetrics to evaluate equipment performance. + Inspects the progress of any building construction and modification and/or equipment installation to current FLBT and GMP standards. + Anticipates future demands for facility maintenance resources and screens and hires staff to support those needs. + Provides staff development and training for operations personnel in the function of facility equipment. + Develops operating budgets including capital requirements to improve productivity. + Monitor and evaluatethe performance of facilities operations, ensuring alignment with organizational goals and quality standards. + Advise onnew developmentsimpactingprofit, schedules, costs, relations, and inter-departmental cooperation. + Develop and implement emergency responseplans to ensure safetyand facility readiness in crisis situations. + Other duties as assigned. **_Required Skills & Abilities:_** + Extensive Knowledge offacilitiesmaintenance,building management,equipmentoperations,andmechanicalandelectrical/electronic systems and processes. + Work closely with Texas A&M maintenance and support stafftoproperlymaintain NCTMfacility. + Strong analytical and problem-solving skills. Possessor canapply these skills to resolve technical problems and gain knowledge about the operation and maintenance of utility/process systems. + This position coordinates and communicates with other departments using complex biological and scientific processes and equipment. This position requiresstrong communicationskills and must be well versed inthebio-tech industry. + Working knowledge of industry practices and regulations (e.g.GxP, ISO, ICH, Annex 1, etc.) across multiple health authorities (e.g.FDA, EMA, MHRA, etc.). + Extensiveexperiencewithclientsandregulatoryaudits. + Knowledge and understanding of OSHA, EH&S, EPA, and state of Texas requirements. + Proficient with MS Office productsandproject management software. + Strong project management, interpersonal, cross- cultural, communication,negotiationand problem-solving skills. + Demonstrate leadership and mentorship skills. + Must have experience working in the following areas: + HVAC Systems supplying controlled conditioned air to clean room and non-clean room environments for containment and elimination of cross contamination + Chillers and Chilled WaterSystems + Boilers and SteamSystems + Water Systems (RODI, Purified,and/or WaterforInjection Systems, multiple buildings) + Process Gases including Instrument/Process Air, CO2, O2 Systems + Refrigeration(Cold Rooms, Freezers, Refrigerators) Systems + Building Automation/Monitoring and Control Systems + Building Security/Access Systems + Waste Inactivation and Neutralization Systems + Fire Alarm and Fire Suppression Systems + Drafting and implementing Standard Operating Procedures for maintenance, pest control,metrology,and other facility functions. **_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 employeeis regularly required to: + Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching. + Utilize hand-eye coordination and manual dexterity tooperateportable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment. + Regularly lift and move objects weighing up to 50 pounds. + Climb ladders and stairs of varying heights. + Work under conditions that may be wet or humid. + Provide support during off shifts, weekends, and holidays as needed. + Work in outdoor weather conditions and noisy environments. + Offer 24/7 support for company activities. + Maintain mandatory attendance. **_Qualifications:_** + Master of Sciencedegree in engineering/technical field with 12years of qualified experience in aFacilities/Engineeringrolein a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR + Bachelorof Sciencedegree in engineering/technical field with 14years of qualified experience in aFacilities/Engineeringrole in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency + A minimum ofeight(8) or more years ofpreviousleadership experience. **_Preferred Qualifications:_** + Knowledge of bio-processingequipment, clean utilities, andsingle usetechnology + Knowledge of Quality management software + Engineeringdegree preferably in Mechanical, Electrical, Chemicalor Biomedical areas. _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._ **Job Locations** _US-TX-College Station_ **Posted Date** _2 months ago_ _(10/28/2025 1:15 PM)_ **_Requisition ID_** _2025-35987_ **_Category_** _Facilities_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

The Manager, CSV will be responsible for management, scheduling, and oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements at each of our 4 Manufacturing Buildings (NCTM, TBF-100, FBF-200, FBF-300). The Validation Manager will be responsible for updating the corresponding manufacturing building's Systems Master List, Requalification Schedule, and management of Validation Engineers/Specialists for day-to-day validation activities. They will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to Associate Director, Validation Work Location College Station, TX Primary Responsibilities: Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals. Supervises the activities of the corresponding manufacturing building's internal validation staff as well as external validation contractors. Establishes validation priorities to ensure that deadlines are met. Pre-approve qualification protocols and post-approve summary reports. Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs). Must be able to create, review, and update SOPs, forms, templates, documentation, and files. Performs other duties as needed. Qualifications: Master's Degree and 5+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR; Bachelor's Degree and 7+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments. Degree in Engineering or Science discipline is preferred. 4+ years' experience in supervision of personnel. Assist in managing the activities and overseeing validation full time employees and/or contractors for the corresponding manufacturing building. Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product. Knowledge of DeltaV automation platform preferred. Working knowledge of engineering principles. Working knowledge and expertise in computerized systems validation. Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred. Thorough knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations. Excellent written and oral communication skills. Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point). Ability to work with minimal supervision. Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility. Role model for company core values of trust, delighting our customers, and Gemba. 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, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Operation of test equipment such as: temperature logger equipment, fog machine, air sampling equipment. Working on ladders. Attendance is mandatory. 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 (******************* or ***************.

: The Finance Business Partner is a pivotal role within the Finance Function, primarily supporting the Associate Director of Financial Planning & Analysis in executing strategic initiatives for the site Finance organization. This position demands a high level of expertise in finance and project management, with a focus on driving efficiency and success in alignment with organizational objectives. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to Associate Director, Financial Planning & Analysis Work Location College Station, TX Primary Responsibilities: Act as the primary finance partner for the site leadership team, ensuring financial insights are integrated into daily operations and strategic decisions. Lead efforts to improve site profitability, identifying key cost drivers, margin opportunities, and efficiency levers across production and support functions. Develop forward-looking tools, forecasts, and business cases that support decision-making and resource allocation at the site level. Improve financial transparency by building clear and consistent reporting structures linked to operational KPIs and business priorities. Support and challenge site leaders on budget adherence, investment cases, and cost-saving opportunities. Collaborate with supply chain, production, quality, and commercial teams to align operational plans with financial performance goals. Contribute to customer pricing discussions by providing accurate costing and profitability insights. Work in conjunction with the Commercial team on program opportunities. Ensure the site's financial inputs to group reporting and forecasts are timely, accurate, and well-grounded in operational realities. Improve Site Profitability. Identify and quantify margin improvement opportunities across production, supply chain, and support functions. Partner with site leaders to develop and track initiatives that directly impact cost efficiency and gross margin. Strengthen Forward-Looking Financial Steering. Develop and maintain reliable forecasting tools and models that provide visibility on future performance. Support scenario planning and proactive decision-making at the site. Increase Financial Transparency. Build robust financial reporting aligned with operational KPIs. Translate complex data into actionable insights for both site and senior leadership, ensuring clear understanding of performance drivers. Support Business Cases and Investment Decisions. Lead financial evaluations of local projects, capital investments, and new customer contracts. Ensure decisions are backed by sound financial rationale and aligned with profitability goals. Ensure Financial Integrity and Operational Alignment. Act as the finance gatekeeper at the site, ensuring that financial plans and reporting are accurate, timely, and aligned with group standards. Work cross-functionally to link operational actions to financial outcomes. All other duties as assigned. Qualifications: Master's degree in Finance, Accounting, Economics or other related field and 5+ years of finance experience, preferably in a manufacturing, pharmaceutical, or CDMO setting; OR, Bachelor's degree in Finance, Accounting, Economics or other related field with 8 years of finance experience, preferably in a manufacturing, pharmaceutical, or CDMO setting. Site-based finance experience highly preferred. Finance experience in biotech manufacturing, CDMO, or pharmaceutical industry highly preferred. Strong business acumen with a proactive, solution-oriented mindset. Solid understanding of manufacturing cost structures, production planning, and how operational KPI's link to financial outcomes. Excellent analytical skills, with the ability to create forward-looking models, forecasts, and actionable insights. Strong interpersonal and communication skills; confident working closely with operational teams and senior site leadership. Experience working with ERP and planning tools (e.g., SAP, Oracle, PowerBI, etc.). High level of integrity and ethical conduct in financial activities. Exceptional attention to detail, with the ability to resolve discrepancies. Well-organized with ability to prioritize. Proficiency with Microsoft Excel. Self-motivated with ability to work independently in a fast-paced environment, prioritizing tasks effectively. Ability to deliver results with a strong sense of urgency. Positive ‘can-do' attitude willing to get the job done and done well. Highly collaborative team player. Excellent stakeholder management skills. Role model for company core values of trust, delighting our customers, and Gemba. 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 essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged sitting, standing, some bending, stooping and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. 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 (******************* or ***************.

The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units. **Company Overview** The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** **Job Description** **_Operational oversight of the following systems dependent upon assignment:_** **Upstream Unit:** + Single-Use Cell Culture Vessels/Bioreactors up to 2000L + Bacterial Fermentation Culture Vessels up to 2000L + Alpha Wasserman Continuous Flow Centrifuges + Disposable Magnetic Mixing Bags and Totes + Cell Expansion and Propagation + Banking/Cryopreservation of Cell Lines and Viruses + Hyperstack, Cellstack and other adherent cell technologies + Plate counting, microscopic examination + Monitor cultures, take samples, turn-around of bioreactor and fermenters,sterilization, and inoculation **Downstream Unit:** + Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration. + Medium to Large-scale Chromatographic systems (ÄKTA) + Pre-Packed Columns from 1L to 100L + Single use mixing systems (Pall & GE) + Single Use connectivity types such as GE DAC and Colder AseptiQuik + Plate counting, microscopic examination + Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation + Bulk filling + Aseptic process simulation and drug product filling **Solution Preparation Unit:** + Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs + Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs + Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures + Integrity testing of filters **_Essential Functions Include:_** + Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc. + Responsible for implementing project safety and quality assurance programs + Execution of SAP functionality for batch close out and generating SAP reports as required. + Develop, write, and review Standard Operating Procedures, Buffer Formulation Records and Batch Production Records (BPRs). + Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations. + Lead deviation resolution and closure with subject matter expert and quality teams. + Responsible for tracking CAPAs to closure. + Provide input and support to R&D functions during development and scale up activities as necessary. + Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes. + Ensure an adequate supply of materials available; ensure all materials for project are procured prior to production. + Maintain the confidentiality of proprietary company information. + Responsible for continuous improvement in areas of responsibility. + Maintain an effective working relationship with others. + Perform all other duties as assigned. **_Required Skills & Abilities:_** + Demonstrated leadership, coaching and mentoring skills. + Demonstrated experience in training others to perform and maintain cGMP standards + Excellent skills with Microsoft Office applications. + Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. + Must be able to work alternative shift hours and weekends as required. + Excellent self-discipline and attention to detail. + Advanced math and computer skills. + Must have exceptional planning and organizational skills, excellent oral and written communicationskills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities. + Demonstrated ability to work with teams and collaborate with others. + 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 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 standing, some bending, pushing, pulling, reaching above the shoulder, stooping, and stretching. + Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. + Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. + Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves. + Ability to lift/pull/push up to 25 pounds frequently and up to 50 pounds on occasion. + Attendance is mandatory. **_Minimum Qualifications:_** + Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with three (3) years of relevant experience; OR + Undergraduate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with five (5) years of relevant experience; OR + Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and seven (7) years of relevant experience; OR + High School/GED with nine (9) years of relevant experience. + A minimum of two (2) years of formal or informal leadership experience required. + A minimum of three (3) years of experience in a GMP environment. **_Preferred Qualifications:_** + Biotechnology Certificate + Green-Belt Certification + Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors produced from such. **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 (******************* or ***************. **Job Locations** _US-TX-College Station_ **Posted Date** _4 months ago_ _(8/20/2025 11:08 AM)_ **_Requisition ID_** _2025-35410_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

The Principal Engineering Manager - Reliability Engineering at Fujifilm Biotechnologies Texas (FLBT) plays a crucial role under the guidance of the Director of Engineering. This position is being established to provide the maintenance and reliability strategy for the department with direct accountability for ensuring equipment/process uptime through management of key metrics (MTTR, MTBF, OBE, OEE) and continuous improvement. In addition, support will be required for maintenance and optimization of the process and equipment across drug substance, drug product and general operational areas. The role combines both a hands-on approach along with leadership skills to perform troubleshooting of equipment, root cause analysis, component and system analyses to identify reliability improvements and reduce risks with design modifications and/or various reliability improvement strategies. Responsibilities may also involve leading process improvements through change control procedures, implementing corrective and preventive actions via the CAPA system and guiding equipment commissioning/qualification. **Job Description** **_Essential Functions:_** + Develop Standard Operating Procedures (SOPs) that define maintenance strategy, reliability engineering, preventative maintenance (PM) and condition-based maintenance (CBM) while collaborating with calibration and maintenance teams. + Collect data and report on equipment/process efficiency metrics (OBE, OEE, OA). + Lead and implement initiatives for equipment/process uptime, including data collection, analysis, parameter changes, etc. + Review, assess and share all areas of maintenance impact on new and modified installations. + Perform Failure Modes and Effects Analysis (FMEAs) for new and existing assets. + Establish asset criticality, determine maintenance, repair and operations (MRO)/spare parts requirements, quantities and order points. + Apply value analysis to determine repair or replacement decision. + Use Root Cause Analysis (RCA), failure analysis and other applicable methodologies to improve equipment reliability, including corrective design changes and implementing maintenance strategy modifications. + Provide framework and training to technicians for the predictive maintenance program, including thermography, vibration, ultrasonic technologies, life-cycle cost analysis and equipment installation requirements. + Perform preventative maintenance optimization. + Analyze equipment failures to determine root cause and implement corrective actions. + Collaborate with Operations and Manufacturing Science and Technology (MSAT) on process and equipment updates to increase reliability. + Evaluate and implement new technologies for enhanced equipment reliability. + Understand the manufacturing equipment/processes on the impact of equipment performance within the manufacturing system. + Prepare necessary material and conduct training to technicians and engineers. + Promote proper use of the computerized maintenance management system and ALCOA+ principles for developing maintenance strategies, execution and documentation. + Request and update capital funding requests to maintain assets. + Provide strategic oversight of engineering activities, troubleshooting support and technical expertise for process equipment and site utilities. + Support client, quality, and regulatory audits and inspections. + Lead and manage new equipment/systems installation, including infrastructure, connectivity, and capability assessments. + Lead and train direct reports in developing change controls for the implementation of new system/equipment installations, process improvements, and site utilities. + Liaise with the CAPEX team for the implementation of capital projects. + Perform all other duties as assigned. **_Required Skills & Abilities:_** + Employ a hands-on approach with problem solving independently or through facilitation with other engineers, technicians, trades, etc. This may include analysis of failed machine tool components such as motors, pumps, gearboxes, etc. + Collaborate effectively with contractors, manufacturing and quality. + Communicate efficiently with both internal and external stakeholders. + Support proper testing, validation, and compliance with regulations. + Develop and review SOPs and maintenance procedures. + Ensure compliance with cGMP, FDA, and EHS guidelines. + Maintain a safe work environment and adhere to safety protocols. + Demonstrate leadership and mentorship skills. + Identify and solve engineering problems efficiently. + Manage multiple projects and priorities effectively. + Proficient in project management software and MS Office Suite. + Strong analytical and problem-solving abilities. + Communicate technical information clearly to various audiences. + Self-motivated and adaptable in fast-paced settings. + Pursue continuous improvement and learning. + Knowledge of biomedical/biotechnical equipment and regulatory standards. **_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: + Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching. + Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment. + Regularly lift and move objects weighing up to 50 pounds. + Climb ladders and stairs of varying heights. + Work under conditions that may be wet or humid. + Provide support during off shifts, weekends, and holidays as needed. + Work in outdoor weather conditions and noisy environments. + Offer 24/7 support for company activities. + Maintain mandatory attendance. **_Minimum Qualifications:_** + Bachelor's degree in engineeringwith ten (10) to fourteen (14) 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 eight (8) to twelve (12) 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 + A minimum of four (4) or more years of previous leadership experience. **_Preferred Qualifications:_** + Knowledge of bio-processing equipment, clean utilities, and single use equipment. + Knowledge of quality management software + Knowledge of both upstream and downstream drug substance processes including drug product operations. + Certified Maintenance & Reliability Professional (CMRP) and/or Certified Reliability Engineer (CRE) Certification. + Engineering degree preferably in Mechanical, Chemical, Electrical or Biomedical Engineering. _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._ **Job Locations** _US-TX-College Station_ **Posted Date** _2 months ago_ _(10/14/2025 9:19 AM)_ **_Requisition ID_** _2025-35866_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

The Sample Management Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples for QC testing. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Primary Responsibilities: Follow Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) Manage test samples, critical reagents, and reference materials Perform shipments to external testing facilities and clients Responsible for cleaning Sample Management laboratories and stocking with necessary supplies Maintaining inventory Excellent written and oral communication skills. Fulfill QC Analyst sample requests Perform other duties as assigned Required Skills & Abilities: Ability to build and foster relationships, cooperation, and collaboration across the organization Aptitude to follow safety procedures outlined in the Chemical Hygiene Plan Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated Excellent attention to detail Computer proficiency required Ability to accurately complete required documentation Excellent written and oral communication skills Excellent organization and analytical skills 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 standing, some bending, stooping, and stretching Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required Ability to sit for long periods to work on a computer Lift up to 15 lbs regularly and up to 30 lbs on occasion Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position Attendance is mandatory Minimum Qualifications: High School Diploma or GED (previous GMP experience preferred). Preferred Qualifications: Associate's degree preferably in Biochemistry, Chemistry, Biology or related field and previous GMP experience preferred. 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 (******************* or ***************.