The QA Project Manager, Program Quality Assurance (PQA) is responsible for providing the PQA team with assistance and oversight of QA projects. As projects evolve and startup activities develop, this position adapts its responsibilities to meet changing needs. The QA Project Manager, PQA focuses on establishing, facilitating, and delivering key performance indicators (KPI), continuous improvement and risk management activities in support of site readiness for operations, start-up and ongoing operations. This role is responsible for administering policies, and effectively addressing and mitigating any issues encountered during assigned activities. 

About the Role

The Sr. Specialist 2, QC Program Management Technical transfer (TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

The Manufacturing Support Associate 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.  

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others.  This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This position will ensure drug product manufacturing start up phase is supported from a knowledge standpoint and will then help the supervisor lead the manufacturing effort after start up phase.

The Associate Director, Digital Manufacturing leads and drives the Recipe Driven Operation (RDO) design for the global implementation at FUJIFILM Biotechnologies. This role also leads the global technology transfer activities and standards definition as they relate to Automation while defining and supporting the governance for life cycle of RDO and Configuration Environment for Batch Activities (CEBA). This role continues to develop as the organization evolves.

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment.. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

Summary: 

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.

Summary: 

The Senior Accountant is responsible for overseeing the accounting, reporting and analysis of FUJIFILM Biotechnologies in TX accounting functions.  Responsibilities will include fixed assets as a primary function as well as month end close, data analysis, and operational accounting. This role requires to be highly organized, with a solid technical accounting knowledge base and excellent communication skills. The position involves successfully handling multiple projects with established timelines while ensuring audit readiness.

Summary:  The Computer System Validation (CSV) Engineer II, under general direction, will be responsible for drafting and executing validation protocols for computer systems, process control systems, as well as preparing validation final reports and all applicable lifecycle documentation.

This role performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.   

Position Description

We are hiring a MSS Manufacturing Supervisor. The MSS Manufacturing Supervisor will be responsible for all departmental production activities for manufacture of non-GMP products in the EMS Plant. They will act as a working supervisor performing manufacturing tasks as well as providing leadership to the manufacturing team.

Territory Manager - Hartford - Remote

As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment.  This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools. 

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the Hartford, CT area

The Automation Engineer 3, DSM Downstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Downstream process areas including Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing. 

The Automation Engineer 2, DSM PI Data Historian, will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.

This position is responsible for completing the daily and continuous cycle counting activities generated through SAP. This person will also be involved in the serialization process as well as inventory discrepancy resolution.

The Scientist 1, QC Analytical Development (AD) Bioassay coordinates the transfer of cell- and plate-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The Scientist 1, QC AD Bioassay ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role periodically interfaces with customers and cross-functional teams to scope bioassay analytical testing plans and achieve project milestones. This role authors and reviews transfer plans, method transfer documents, and transfer summary reports to support tech transfers for QC Analytical Development.

As the Sales Operations Specialist, you will oversee the daily management of sales orders and provide necessary presale support.  Your role includes optimizing processes and managing projects to meet the needs of both internal and external stakeholders, including customers, the sales team and other departments. Success in this position involves streamlining order management processes and workflows to eliminate data and system inefficiencies.  You’ll be responsible for defining functional responsibilities to ensure timely and accurate order fulfillment, while maintaining a high standard of integrity to minimize manual corrections.  Additionally, you will become proficient in the Quoting Tool, testing new releases, and offering support to Sales and Sales Operations teams.