The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.

This position reports into the Marketing organization and manages the Interventional GI & Accessories team. The product portfolio includes innovative endoscopes for ERCP, EUS and Double Balloon Enteroscopy as well as accessories for endoscopic procedures. This role works cross-functionally both within the organization and with external stakeholders (e.g., KOLs) to execute company initiatives and manage all aspects of product commercialization, including both upstream and downstream marketing. The Senior Product Manager, Interventional GI & Accessories contributes to the evolution of the organization as new protocols and business methods gain adoption and the priorities of the division continue to change.

Who We Are

FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, Arizona facility for a New Product Introduction Engineer - CMP Pilot Plant!  

With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process. 

The Role

The Pilot Plant Lab Engineer supports process development and the production of low-volume products. Key responsibilities include performing SAP transactions, contributing to CIP projects, conducting Engineering Reviews, and managing equipment. Additionally, the role involves collaborating within the team and across departments to achieve project goals effectively.

QVS Engineering is a growing team whose mission is to improve the quality of FFSS products through their life cycle, proactively handling component and module obsolescence while strategically reducing COGS (Cost of Goods Sold). The QVS Electrical Engineer III works with a cross-functional team to resolve complex ultrasound systems’ quality issues, defining and implementing innovative modifications to existing electrical designs to reduce cost while still maintaining high quality, and handling obsolescence of electrical/electronic components. Specific requirements include electronic troubleshooting experience using standard lab equipment on circuit boards, expertise in power supplies/power converters, low power design, electronic component selection, and grounding schemes. Previous experience working with FDA-regulated products is highly desired.

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.

The Ultrasound Clinical Applications Specialist has the overall responsibility for providing excellent customer service along with the clinical and technical expertise in the demonstration and training of Fujifilm ultrasound equipment. This position assists in the sales process through product demonstrations and supports the company's goals in all interactions with customers. Additionally, the Ultrasound Clinical Applications Specialist is called upon to provide training and support to fellow Applications Specialist, Account executives, and Field Service Technicians.

The Scientist 2, QC Microbiology, Drug Product & Raw Materials supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology, DP & RM effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required.

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation

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.

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.

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.

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 DeltaV Infrastructure, 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.

The Associate Manager of Manufacturing leads daily manufacturing operations during a 12-hour shift. This position is responsible for managing a cross-functional team of technicians executing cell culture and microbial fermentation processes using both single-use technologies and stainless steel, ensuring compliance and efficiency in a fast-paced, modular multiproduct environment. This role has direct impact on the delivery of manufacturing focused site key performance indicators (KPIs). Additionally, this role incorporates prior hands-on bioprocessing experience, thrives in a regulated and client-facing environment, and demonstrates operational leadership and mentorship across varying clinical and commercial production phases.

FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, AZ facility for an Account Manager!

With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process. 

The Role

The Account Manager will plan and implement sales/account strategy to grow territory and achieve sales targets for multiple FUJIFILM Electronic Materials (FFEM) customers. Take direction from (GAM) Global Account Managers interface with local and international business teams, engineers, and other customer service to sell and service FFEM products.

The Equipment Maintenance Technician is responsible for the maintenance of wafer fabrication assembly and facilities equipment for production lines. Responsible for troubleshooting and repairing downed equipment and assisting engineering staff in establishing and implementing periodic equipment maintenance. Uses test and diagnostic equipment to perform checkouts. Rebuilds manufacturing equipment. Technician may participate in safety forums, Emergency Response Teams and station improvement teams.

• SKILL: Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks.
• JOB COMPLEXITY: Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.
• SUPERVISION: Normally receives little instruction on daily work, general instructions on newly introduced assignments.
• EXPERIENCE: Typically requires a minimum of 2 - 4 years of related experience.

This position's schedule is considered a Compressed Work Week - Front End Days - Every Sunday, Monday, Tuesday, and every other Wednesday.  5:30 am - 6:00 pm

This position reports to the Maintenance manager. Responsible for performing entry level to complex troubleshooting and repair techniques on manufacturing equipment; electrical/electronic and mechanical systems.  Responsible for analyzing, troubleshooting, maintaining, and repairing complex equipment.  Assist in modifications to existing machinery and equipment to facilitate new production techniques and/or improved equipment reliability.

This position is intended to process all outgoing shipments, incoming purchase orders, incoming goods, schedule and process parts for repair, maintain the order and the neatness of the warehouse, assist in the physical counts of inventory, respond to off-hours emergency parts requests, and perform all other duties as assigned.

The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) 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 Director collaborates with cross-functional teams to drive continuous improvement and optimize CV practices.