The QA Specialist III, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.  

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 Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. 

Summary:  The Quality Assurance - Compliance Specialist III - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

The Planner 2, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role uses knowledge of maintenance processes and regulatory requirements to plan, schedule, and coordinate maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role seeks opportunities for continuous improvement and collaborates cross-functionally to ensure successful completion of maintenance activities.

The Scientist 1, Global QC Raw Materials (Microbiology) liaises with various external collaborators, contract laboratory organizations, QC testing teams and QA groups to ensure training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with the pharmacopoeias and ICH guidelines. This role generates protocols and reports to support tech transfer activities and performs change control assessment activities for tech transfers to include, implementation of new raw materials, new test laboratories, specifications updates e.g. new methods and new vendors.

The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within the Quality Control Raw Materials department as it relates to Investigations, Deviations, CAPAs and Change Controls. This role supports continuous improvements initiatives, customer contacts, and CLO communications to ensure Global QC Raw Materials (RM) capability of onboarding new materials, updating existing materials, implementing methods and ensuring campaign readiness as applicable.

The Sr. Specialist 2, Global QC Raw Materials (Documentation) is responsible for, but not limited to, implementing new raw materials, including specification authoring, requesting LIMS builds, and assessing changes. This role participates in planning and tracking QC readiness for clinical and commercial manufacturing, and ensures all documentation is in accordance with Good Manufacturing Practices (GMP) and that all reported results are accurate. The Sr. Specialist 2, Global QC Raw Materials onboards new materials in line with Fujifilm Diosynth Biotechnologies (FDB) and customer expectations. This role authors events, deviations, and CAPAs related to new materials, specifications, and other tech transfer activities.

The Scientist 1, Global QC Analytical Development Raw Materials is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth Quality Control Laboratory and external contract laboratory organizations (CLOs). This role liaises with customers, CLOs, QC testing teams, and QA groups to plan and track QC raw materials readiness for clinical and commercial manufacturing, which includes ensuring training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with all GMP (Good Manufacturing Practices) regulatory guidelines. 

Summary: Laboratory Engineering Technical Support I is an entry-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring.  Under...

The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.  

Summary:  The Manufacturing Process Engineer I is an integral part of the Manufacturing Technical Operations department located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Manufacturing.

The Sr. QC Data Reviewer is responsible for ensuring compliance with Fujifilm’s Quality systems, policies, and procedures in accordance with U.S. and international regulatory agencies, ICH, general cGMP, and international guidance. This role involves leading the data review process to ensure accuracy, thoroughness, and timely completion in collaboration with cross-functional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration.

Summary:  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.  

The Manufacturing Support Associate 3 plays a crucial role in maintaining compliant and reliable production, with adhering to cGMP regulations and industry guidelines. This position leads compliance initiatives, oversees corrective and preventive action (CAPA) execution, and coordinates batch planning, all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and accommodate inspections and audits.

The Associate Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate...

The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.  

The Client Coordinator Administrative Assistant will provide comprehensive assistance and support to the program management team as well as facilitating client-facing site visits and coordinating internal and external events. This role is key to ensuring smooth operations and exceptional client interactions while supporting client-facing teams in significant matters requiring their attention.

The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex manufacturing investigations, identify root cause, and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors, internal auditors, and senior leadership, as needed regarding the findings of investigations. Additionally, this role mentors and provides guidance to junior investigators throughout the investigation process.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.