Fujifilm Holdings America Corporation jobs in College Station, TX

- 23 jobs

Sr Manager-Facilities Support Operations
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
The Sr. Manager - Facilities Support Operations under the leadership of the Director of Facilities will be responsible for managing the daily maintenance operations including the CCMS/CMMS operation, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities. This position will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Biotechnology Facility. This position will coordinate with other team members, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality, and external suppliers to provide a high level of excellence over the maintenance operational activities of FLBT. Also, this position should ensure that departmental milestones and goals are met in accordance with the approved plans and budgets. 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: *************************************************** Essential Functions: Accountable as a system owner for the management, and operation of the Blue Mountain Regulatory Asset Manager (CCMS/CMMS) across multiple facilities. Responsible to work with eQMS (system administrators) when changes, configuration and improvements are required for the Blue Mountain Regulatory Asset Manager (CCMS/CMMS). Accountable for the daily maintenance operations including work order lifecycle process, Planning & Scheduling activities, and MRO inventory across multiple facilities. Accountable for the maintenance/calibration events and Bill of materials creation and management. Develop, implement, and maintain the MRO inventory strategy across multiple facilities. Work effectively with other team members and system users on system issues pertaining to the CCMS/CMMS system. Responsible for coordinating facility shutdowns including systems and equipment, to ensure safety, minimize disruptions and maintain compliance with operational compliance. Make recommendations to the site leadership team for possible improvements to the CCMS/CMMS system. Evaluate CCMS/CMMS data to identify MTBF and identify potential improvements including PDMs program, RCM, and RCA methodologies among others. Conduct periodic reviews and reports for the CCMS/CMMS performance and user's utilization. Work directly with Manufacturing, Validation, Quality Assurance, Metrology, Maintenance, Facilities, and Quality Control to support their individual department needs related to the CCMS/CMMS. Meet with internal customers to plan and schedule calibration and maintenance activities for their instrumentation, systems and equipment across multiple facilities. Maintain workload balance across the Metrology and Maintenance Departments. Responsible for developing, writing, editing and/or reviewing SOPs for the maintenance operations. Develop, implement, maintain, and monitor departmental KPIs in order ensure a high level of efficiency. Be able to handle multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels. Always ensure departmental cGMP regulatory compliance. Oversee and provide leadership to the facilities support operations staff across the multiple facilities. Assist the Director of Facilities and the Executive Leadership Team in establishing strategic directions for the maintenance operations resources and activities and setting objectives to maximize the value of the organization. Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities. Maintain a positive, professional, and customer-oriented attitude. Assist with writing job descriptions, interviewing and hiring the personnel needed to support the maintenance operations. Hire, train, develop and evaluate maintenance operations staff. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with the Director of Facilities and Human Resources as appropriate. All other duties as needed. Required Skills & Abilities: Strong leadership qualities and skills. Strong knowledge of Blue Mountain RAM implementation, Calibration Procedures, and Maintenance Procedures. Knowledge of a wide variety of typical maintenance tasks, including PM, spare parts, work order lifecycle and troubleshooting systemic problems. General principles of engineering, operations and the tools and equipment required to perform many of the daily maintenance tasks. Strong written and verbal communications skills, be self-motivated and possess interpersonal skills. Ability to work quickly and effectively without constant supervision. Ability to supervise skilled personnel in support of the maintenance operations. Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems. Project management skills. Detail oriented and accurate. Ability to coordinate, facilitate and organize resources. Ability to develop strategic relationships and develop employees within the organization. Ability to work effectively under extreme pressure to meet deadlines. Well organized with ability to handle multiple activities simultaneously. Ability to work in a fast paced, state of the art, alternately research and customized manufacturing facility. Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint) as well as use of Computerized Maintenance Management System, CMMS. In-depth knowledge of calibration, maintenance, and documentation requirements for cGMP manufacturing. Experience in Start-Up & Commissioning of cGMP Facility. This role will require a high level of personal organizational skills, experience and drive. The successful candidate must have a vision of a final state, fully organized group to operate in a highly regulated GMP environment. 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. Qualifications: Bachelor's degree in a maintenance/facilities or related discipline with a minimum of eight (8) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR Associate's degree in a maintenance/facilities or related discipline with a minimum of ten (10) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR High school diploma or general education degree (GED) in a maintenance/facilities or related discipline with a minimum of twelve (12) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency A minimum of five (5) or more years of previous leadership experience. Preferred Qualifications: Knowledge of Blue Mountain Regulatory Asset Manager CCMS/CMMS. Knowledge of quality management software Knowledge of bio-processing equipment, clean utilities, and single use technology Previous experience in a planning/scheduling role. 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 ***************.
$100k-146k yearly est. Auto-Apply 49d ago
Upstream Manufacturing Technician III
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be: 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 Essential Functions: Upstream Unit: Single-Use Cell Culture Vessels/Bioreactors up to 2000L Bacterial Fermentation Culture Vessels up to 2000L Alpha Wasserman Continuous Flow Centrifuge 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 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 daily cleaning and sanitization of the laboratory and manufacturing areas. Maintain an effective working relationship with others. Perform all other duties as assigned. 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 daily cleaning and sanitization of the laboratory and manufacturing areas. Maintain an effective working relationship with others. Perform all other duties as assigned. 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 work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours to include night shift hours and weekends as required. 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. Minimum Qualifications: Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with one (1) year of relevant manufacturing experience in GMP or regulated industry; OR Associate degree / Technical certification in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with two (2) years of relevant experience, one (1) of which should be in manufacturing, GMP or regulated industry; OR High School/GED with four (4) years of relevant experience, two (2) of which should be in manufacturing, GMP or regulated industry. Preferred Qualifications: GMP experience Biotechnology certificate preferred. Cross training with other identified functional 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 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.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 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 ***************.
$25k-38k yearly est. Auto-Apply 7d ago
Upstream Manufacturing Lead
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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 ***************.
$67k-112k yearly est. Auto-Apply 26d ago
Associate Director-Communications
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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.
$70k-121k yearly est. Auto-Apply 60d+ ago
Document Control Specialist II
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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.
$32k-46k yearly est. Auto-Apply 28d ago
Head of People & Culture
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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.
$82k-118k yearly est. Auto-Apply 7d ago
Manufacturing Compliance Coordinator II
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
The Manufacturing Compliance Coordinator II assists with the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities. 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 Essential Functions: Responsible for participating in the following activities within the Manufacturing Support Services function: Work collaboratively with site management to instill a ‘Quality Culture' by coaching Manufacturing staff in the application of GMP Principles including the underlying rational of those principles. Compliance Support the Quality and Manufacturing organization during internal and supplier audits Support the external and internal Audit Programs to be in an acceptable state of compliance Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products Responsible for Manufacturing audit preparations, conducting internal audits, assisting client audits with site documentation collation Coordinate batch and formulation record review and corrections to executed records. Coordinates the initiation of new deviations. Leads deviation, CAPA, and change control closure for Manufacturing, including initiation of New Product Introduction change controls. Assists with leading Root Cause Analysis Investigations Assists with leading Problem Analysis (PA) events. Assists with leading After Action Reviews (AAR). Schedules and facilitates post manufacturing campaign lessons learned. Supports leading the completion of periodic reviews. Provides and maintains metrics around batch closure, including deviation, CAPA and change control status. Deviation Investigation Participate and support investigations for deviations and events. Participate in investigations and assist in identification of root and/or contributing causes. Ensures required Management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders. Support client due diligence and Quality audits as well as regulatory inspections. Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Equipment Compliance Coordination Is the Primary Point of Contact for any equipment related servicing and or Out of Service requests. Support the routine maintenance and calibration of manufacturing equipment by the monitoring and scheduling of any preventative or corrective work required. Work directly with the Facilities group to plan and support any on-site vendor support/maintenance activities including escorting on-site visitor requirements and complete any specific access required information. Ensure all equipment utilized on the floor for manufacturing execution is entered correctly into the Building Management System. Is the point of contact for client and regulatory inspection support with trends and metrics. Leads the input on scheduling of planned down-time for all manufacturing equipment. Leads the facility shutdown planning and associated change controls with respect to manufacturing equipment and facilities. Leads the Production Floor GEMBA walks to identify any issues/problems that need addressing to remain in compliance. Leads routine walk throughs of the facility and submit any work orders for items found. All other duties as assigned. Required Skills & Abilities: Excellent oral and written communication skills, interpersonal and organizational skills. Excellent organizational, analytical, data review and report writing skills. Practical understanding of equipment used in bioprocessing (downstream and/or upstream). Proficient with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Experience working in cleanroom environments. Must have good planning skills and must be willing to interface with and support team members 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. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds, on occasion. Attendance is mandatory. Qualifications: Bachelor's Degree and four (4) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR Associate degree and six (6) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.; OR High School Diploma or GED and eight (8) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role. Preferred Qualifications: Experience with cell culture and purification processes Experience authoring CAPAs, change controls, and deviations 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 ***************.
$44k-64k yearly est. Auto-Apply 22h ago
Senior Scientist, QCAT Cell Biology
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
: 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 ***************.
$53k-86k yearly est. Auto-Apply 38d ago
Associate Director-Human Resources
Fujifilm Holdings America 4.1
Fujifilm Holdings America job 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.
$67k-102k yearly est. Auto-Apply 34d ago
CAD Specialist
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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.
$39k-58k yearly est. Auto-Apply 28d ago
QC Sample Receipt Analyst I
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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 ***************.
$37k-55k yearly est. Auto-Apply 7d ago
Director of Facilities
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
The Director of Facilities at Fujifilm Biotechnologies Texas (FLBT) is responsible for overseeing 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, maintaining a safe, functional, and welcoming environment for employees and visitors alike. Job Description Essential Functions: Oversee overall building operations, including maintenance and metrology, site services, planning and scheduling, MRO, Security, and compliance groups. Responsible for the operation and maintenance of facility systems such as but not limited to HVAC, RO/DI water, WFI, Clean Steam, Clean Gases, Boilers, Chillers, Electrical, UPS, Back-Up Power, Waste, etc. Oversee housekeeping, space planning, landscaping, and parking facilities to maintain a 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, ensuring optimal efficiency and functionality. Ensures proper operation of systems in compliance with required regulations and codes. Conduct troubleshooting of facility infrastructure and production equipment. Implement and manage planned maintenance programs utilizing historical data and metrics 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 evaluate the performance of facilities operations, ensuring alignment with organizational goals and quality standards. Advise on new developments impacting profit, schedules, costs, relations, and inter-departmental cooperation. Develop and implement emergency response plans to ensure safety and facility readiness in crisis situations. Other duties as assigned. Required Skills & Abilities: Extensive Knowledge of facilities maintenance, building management, equipment operations, and mechanical and electrical/electronic systems and processes. Work closely with Texas A&M maintenance and support staff to properly maintain NCTM facility. Strong analytical and problem-solving skills. Possess or can apply 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 requires strong communication skills and must be well versed in the bio-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.). Extensive experience with clients and regulatory audits. Knowledge and understanding of OSHA, EH&S, EPA, and state of Texas requirements. Proficient with MS Office products and project management software. Strong project management, interpersonal, cross- cultural, communication, negotiation and 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 Water Systems Boilers and Steam Systems Water Systems (RODI, Purified, and/or Water for Injection 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 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. Qualifications: Master of Science degree in engineering/technical field with 12 years of qualified experience in a Facilities / Engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR Bachelor of Science degree in engineering/technical field with 14 years of qualified experience in a Facilities / Engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency A minimum of eight (8) or more years of previous leadership experience. Preferred Qualifications: Knowledge of bio-processing equipment, clean utilities, and single use technology Knowledge of Quality management software Engineering degree preferably in Mechanical, Electrical, Chemical or 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.
$60k-99k yearly est. Auto-Apply 49d ago
QC Supervisor, Chemistry
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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 ***************.
$58k-92k yearly est. Auto-Apply 20d ago
Head of Finance
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
As Head of Finance at the Site in College Station Texas, you will be leading and driving the finance related initiatives across the site and taking these with you into the Site Leadership Team. The Head of Finance is a key member of the Site Leadership team who will provide effective finance business partnering, providing the right information at the right time to enable and influence effective business decisions. The Site Finance team includes finance accounting, site finance controlling, treasury and cashflow forecasting, working capital management, site capital and fixed assets, forecasting and budget setting as well as medium term and long-term plans. Job Description Essential Functions: Take an active leadership role in the site leadership team by supporting and challenging the business areas and support and drive the site development through expansion and new business development. Responsible for setting the direction and vision for the Finance organisation, driving the organisation to be a valued and efficient business partner. Leading your direct reports on their journey towards optimizing their respective teams to efficient and value adding financial operations. Continouts development of the team around you is essential, focusing on optimizing and stabilizing the financial operations on the growth journey as well as developing a high performing, motivated and competent team. Ensure financial transparency and insights that supports effective and correct decision making. This includes preparation of business plans and financial forecasting for ventures or projects being consideretd at site. Drive and control active working capital management to optimize cashflow for the site. Working closely with the site leadership team and management teams to ensure they understand the importance of profitability and active cash management. Full P&L and Balance sheet responsibility; Ensure financial house in order enabling successful external and internal audits and adherence to USGAAP, IFRS and FLB accounting policies and standards as well as compliance with internal controls and JSOX Ensure that the Site Finance team is contributing actively to the transformation and alignment that is currently a big focus area in the FLB Global Finance organisation. Other job duties as needed. Scope/Accountability: The Head of Finance will regularly interact with its peers in the Site SLT as well as Senior Stakeholders in the Global roles of FLB. The Head of Finance is fully accountable for ensuring full transparency on Financial status as well as financial compliance at FLBT. The scope of this role encompasses leading and expanding the FLBT Finance department to become a function that can guide the site to accomplish its strategic goals. The Head of Finance is expected to optimise the processes within Finance to ensure a high level of efficiency in the department. Required Skills and Abilities: Ability to be the courageous challenger to the status quo, especially in financial matters. Driving change and alignment with the right problem-solving attitude finding the solution that fits everyone. Excellent communication skills with the ability to communicate and convey concise information. High level of attention to detail with very good analytical and data management skills. Experience of working with multi-site, multinational organizations on different time zones. Able to build and maintain effective and credible relationships with key stakeholders. Significant experience in or knowledge of USGAAP accounting principles with demonstrated experience in rolling out changes to accounting principles. High proficiency with and knowledge of accounting and financial management software including SAP, Microsoft Excel, and others. Demonstrated ability to work across functional and intercompany boundaries to develop and maintain relationships with diverse internal and external business customers. Role model for company core values of trust, delighting our customers, Gemba, and Genki. Impact/Influence: The Head of Finance will set financial targets for the site ensuring that the site P&L is optimised. The Head of Finance is accountable for financial compliance and eliminating financial surprises. Minimum Qualifications: Bachelor's degree in finance or business required. CPA, Certified Management Accountant certifications, or MBA preferred. At least 12-15 years of experience in increasingly responsible financial roles. 10+ years in a supervisory/management role in a financial or related field, preferably in a manufacturing environment. Also requires a demonstrated track record in the following key areas: Attainment of aggressive growth, improvement and profit objectives. Execution of strategic plans that optimize growth and competitive positions Strong collaboration and team building skills Strong communication skills A strategic thinker, able to motivate, lead and develop subordinates. Experience of leading finance teams at a Senior level within a larger corporation and being part of a leadership team. Understands of the importance of Strategy and its role in driving a business forward. Natural self-starter with a systematic and dynamic approach to work. 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.
$96k-128k yearly est. Auto-Apply 32d ago
Financial Business Partner
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
: 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 ***************.
$63k-111k yearly est. Auto-Apply 38d ago
Associate Director, Microbiology
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
As the Associate Director of Microbiology, you will play a pivotal role in overseeing all microbiological testing and ensuring the highest standards of quality, data integrity, and compliance at our manufacturing site. You will leverage your expertise to guide our efforts in maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance. 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 Head of Quality Control Work Location College Station, TX Primary Responsibilities: Microbial Testing Oversight: Lead and manage all aspects of microbiological testing, including sterility, bioburden, endotoxin testing, and environmental monitoring for our manufacturing processes. Quality Assurance: Develop and implement microbiological quality control procedures to ensure compliance with FDA, EMA, and other relevant regulatory guidelines. Data Integrity: Ensure all microbiological data is complete, accurate, and securely maintained. Uphold the integrity of all lab records and ensure compliance with ALCOA++ principles. Team Leadership: Manage and mentor a team of microbiology professionals, fostering a positive and collaborative work environment. Process Improvement: Identify opportunities for process enhancements and innovation in microbiological testing methods to increase efficiency and accuracy. Risk Assessment: Collaborate with site's contamination control expert to conduct risk assessments and implement risk mitigation strategies related to microbial contamination in manufacturing processes. Regulatory Compliance: Prepare for and participate in internal and external audits, providing expertise and ensuring all microbial testing meets regulatory standards. Cross-Functional Collaboration: Work closely with the Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and ensure seamless operations. Documentation and Reporting: Ensure accurate documentation of all microbial testing activities and results, providing clear and comprehensive reports to senior management. Technology Adoption: Stay updated with the latest advancements in microbiology testing technologies and incorporate relevant innovations into existing processes. All other duties as assigned. Qualifications: PhD. in Microbiology, Biology, or a related field and 4+ years of relevant experience in biopharmaceutical manufacturing; OR, Master's degree in Microbiology, Biology, or a related field and 7+ years of relevant experience in biopharmaceutical manufacturing; OR, Bachelor's in Microbiology, Biology, or a related field and 9+ years of relevant experience in biopharmaceutical manufacturing. 5 years of experience in a leadership role required. Experience in a CDMO environment is highly desired. Proven experience managing microbiology laboratories and leading teams in a manufacturing environment. In-depth knowledge of regulatory guidelines, quality systems, and data integrity principles including cGMP and ALCOA++. Strong problem-solving skills and a proactive approach to identifying and mitigating microbial risks. Exceptional communication and leadership skills, with the ability to work effectively in a cross-functional team setting. Demonstrated ability to manage multiple projects and priorities in a fast-paced environment. 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 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 as needed. Onsite attendance 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. *LI-Onsite 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 ***************.
$93k-142k yearly est. Auto-Apply 60d+ ago
Manufacturing Supervisor, Upstream
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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 communication skills, 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 ***************.
$62k-85k yearly est. Auto-Apply 60d+ ago
Principal Engineering Manager-Reliability Engineering
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
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 engineering with 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.
$110k-155k yearly est. Auto-Apply 49d ago
QC Analyst I, Microbiology
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
The Microbiologist I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Texas Quality Control Laboratory. 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: Collect environmental monitoring (Total Air, Viable Air and Viable Surface) in a cleanroom/controlled environment. Collect Utility Monitoring Samples (RODI/WFI) routinely and for qualification of systems. Sample Compressed Gas/Process Gas system. Autoclave materials and components for use in the QC laboratory. Routine QC laboratory cleaning Management of inventory items for the laboratory Ensure the lab is maintained (organized, clean, & properly supplied). Perform other duties as assigned. Qualifications: Associate's degree preferably in Biochemistry, Chemistry, Biology, or related field; OR, High School Diploma or GED and 1+ year of relevant experience. Ability to analyze raw data, assess assay and system suitability criteria. Ability 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. Good attention to detail and ability to utilize problem solving/trouble shooting skills. Good computer skills. Demonstrated written and oral communication skills. Strong organization and analytical skills. Role model for company core values of trust, delighting our customers, Gemba, 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. 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 lift/pull/push 50 lbs on occasion and 15 lbs regularly. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Attendance is mandatory. 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 ***************.
$37k-55k yearly est. Auto-Apply 36d ago
Senior Project Manager
Fujifilm Holdings America 4.1
Fujifilm Holdings America job in College Station, TX
The Senior Project Manager is responsible for leading and executing strategic projects within the site, ensuring alignment with organizational goals and regulatory standards. This role involves managing multiple projects from inception to completion, optimizing project delivery, and fostering cross-functional collaboration to achieve business objectives. Job Description Essential Functions: · Lead the planning, execution, and closure of complex and high-value projects, ensuring they are completed on time, within scope, and within budget. · Develop and implement project plans, including defining project scope, goals, deliverables, resources, and timelines. · Coordinate and manage project teams, promoting effective communication and collaboration across departments. · Identify and analyze project risks, implementing strategies to mitigate and manage them effectively. · Liaise with stakeholders to capture requirements, provide updates, and ensure alignment with project objectives. · Monitor and report on project progress, financials, and key performance indicators, ensuring transparency and accountability. · Drive continuous process improvement initiatives, RCAs, sharing best practices and lessons learned across projects. · Utilize project management methodologies including Agile, Scrum, Waterfall, and Sprint, with the ability to adapt and apply the appropriate approach based on project requirements and business needs. · Implement technology transformation initiatives, including digital transformation projects and change management strategies. · Mentor and coach Project Managers and Project Coordinators. · Ad hoc or any other task, role, responsibility as directed by Director or Associate Director, PMO. Required Skills & Abilities: · cGMP experience and working knowledge of CDMO or biopharmaceutical operations · Experience of financial acumen and technical writing. · Competent in advanced computer applications (e.g., Word, Excel, LIMS) and enterprise systems. · Working knowledge of continuous process improvement and implementing quality systems (e.g., SOPs, Change Control). Preferred Project Management Competencies: · Communication Skills and Stakeholder Engagement: Good communication and interpersonal skills, with the ability to interact with team members and stakeholders. Capable of clearly conveying information and supporting decision-making processes. Able to build positive relationships that contribute to team success. · Financial Understanding and Resource Use: Basic understanding of financial management principles. Experience with budget tracking and resource allocation in small-scale projects, aiming to align budgets with project goals for efficient execution. · Strong Strategic Planning: Experience with assisting in strategic planning and implementation processes. Ability to set achievable project goals and track progress using performance metrics to meet business objectives. · Demonstrated capabilities of Project Management Methodologies: Well versed with various project management methodologies such as Agile, Scrum, and Waterfall. Ability to apply these methods in project settings to improve outcomes and adapt to changing needs. o Agile: Basic experience with Agile principles for project delivery, promoting flexibility and teamwork. Supporting collaboration between cross-functional teams and learning to manage feedback loops effectively. o Scrum: Familiar with the Scrum framework, including user stories and product backlogs. Participation in sprint planning and meetings to support team alignment and monitor progress. o Waterfall: Understanding of the Waterfall methodology and its structured approach. Able to follow project phases and manage timelines and deliverables under guidance. o Sprint: Basic skills in managing sprint tasks within Agile or Scrum frameworks, focusing on achieving goals within set timeframes and optimizing team productivity. · Experience with Project Management Tools: Exposure to project management software for planning and tracking small to medium-sized projects. Learning to utilize these tools for effective oversight and execution. · Continuous Improvement and Innovation: Support for ongoing improvement initiatives, incorporating lessons learned to suggest innovative practices. Focused on enhancing project delivery and operational effectiveness. · Problem-Solving and Decision-Making: Develop analytical skills to navigate project challenges. Able to contribute ideas for problem resolution and support strategic decision-making. · Change Management Deployment: Apply change management practices and assisting in the adoption of new methodologies and technologies. Understanding of change management principles, strategies, and tools. Ability to manage resistance and drive adoption and sustainment of change. Familiarity with training and development strategies to support change initiatives. 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: · Travel up to 25% of the time · Experience prolonged sitting with some 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. · Have a normal range of vision. · Full-Time on-site attendance is mandatory. Minimum Qualifications: · Bachelor's degree in in Business Administration, Project Management, Engineering, or Bio-Medical Sciences or a related field with 8 years of relevant experience; OR · Associate degree in in Business Administration, Project Management, Engineering, or Bio-Medical Sciences or a related field with 9 years of relevant experience; OR · High School diploma or GED and 10 years of relevant experience. · At least 5 years of experience managing project teams, preferably within a biopharmaceutical environment. Preferred Qualifications: · Degree in Business Administration, Project Management, Engineering, or Bio-Medical Sciences, or a related field. · Previous project management or relevant experience in a biopharmaceutical CDMO environment. 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.
$86k-121k yearly est. Auto-Apply 60d+ ago

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