The QA Validation Specialist will serve as technical subject matter expert for FDBC validation processes including but not limited to, facilities, utilities and equipment qualification (FUE), manufacturing and laboratory systems and computerized equipment (CSV), and validation software tools.  The main responsibility for this role is to provide QA oversight for validation practices at FDBC.  The role will also provide QA oversight for validation related topics by supporting QMS processes and deliverables such as SOPs, site deviations, CAPAs and change control records. The role will work closely with manufacturing, quality control, quality assurance, supply chain, engineering and facilities representatives to ensure compliance of cGMP systems with all internal and regulatory quality requirements.

The successful candidate has proficient understanding of CQV industry best practices and regulatory requirements.  In addition, candidate must have outstanding knowledge of 21CFR Part 11 and EudraLex Volume 4, Annex 11 regulations. excellent communication (written and verbal) skills, can thrive in a fast-paced environment, is quality-minded, detail oriented, and flexible in work schedule availability to meet the demands of a multi-product clinical and commercial phase cellular therapy company.

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 a Purchasing Manager!

The Role

The Purchasing Manager will manage raw material commodity strategies and hold suppliers accountable for top performance in Chemicals, Packaging and MRO. This role is responsible for securing best overall value while continuing to ensure that purchased materials support quality, cost, delivery, and service levels. This position works closely with Finance, Quality, Manufacturing, Engineering, R&D and Facilities, provides leadership in problem solving, price negotiations, cost containment strategies and enhancing supplier relationships.

The Clinical Specialist (ARDMS Certification Required) - Minneapolis, MN position is responsible for understanding and addressing the clinical needs of customers within an assigned territory.  The Clinical Specialists partner with Territory Managers to demo FUJIFILM Sonosite products, close deals, and ensure ongoing positive customer experience.  After the sale, this role owns client relationships and works to encourage customer adoption and use of FUJIFILM Sonosite products.

Note: This position is open to candidates who currently reside in the greater Minneapolis, MN or St. Paul, MN area as this would be a central location relative to the territory's business.

Regional Sales Manager - South Central - Remote

This position is responsible for meeting the monthly, quarterly, and annual regional sales quota.    Provide direction and leadership for regional sales team.  Direct management responsibility for sales Territory Managers, including performance management, skill development, coaching and mentoring of sales technique and territory management.

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the South Central US area

We are hiring a Bioprocess Specialist. The Bioprocess Specialist will be responsible for sales of Fujifilm’s Life Sciences Bioproduction Products.

This position will support the Poland/Netherlands/Slovakia markets.

We are hiring a Bioprocess Specialist. The Bioprocess Specialist will be responsible for sales of Fujifilm’s Life Sciences Bioproduction Products.

This position will support the UK/France/Ireland markets.

We are hiring a Cell and Gene Therapy Specialist. The Cell and Gene Therapy Specialist will be responsible for sales of Fujifilm’s Life Sciences Cell and Gene Therapy Products.

This position will support the United Kingdom market.

We are hiring a Bioscience Account Manager. The Bioscience Account Manager will be responsible for sales of Fujifilm’s Life Science Products.

This position will support the Israel/Turkey/Russia markets. The ideal candidate will be based within the assigned territory. This position will support Cyprus, Israel, Oman, Russia, Turkey and the Middle East.

We are hiring a Bioscience Account Manager. The Bioscience Account Manager will be responsible for sales of Fujifilm’s Life Science Products.

This position will support the Austria/Germany/Netherlands markets. The ideal candidate will be based within the assigned territory. The role will support Austria, Belgium, Czech Republic, Germany, Netherlands and Switzerland.

We are hiring a Bioscience Account Manager. The Bioscience Account Manager will be responsible for sales of Fujifilm’s Life Science Products.

This position will support the Ireland/UK markets. The ideal candidate will be based within the assigned territory. The role will support the UK and Ireland markets.

We are hiring a Bioscience Account Manager. The Bioscience Account Manager will be responsible for sales of Fujifilm’s Life Science Products.

This position will support the Bulgaria/Poland/Slovakia markets. The ideal candidate will be based within the assigned territory.  The role will support Bulgaria, Estonia, Lithuania, Latvia, Hungary, Poland, Romania, Slovakia and Ukraine. 

We are hiring a Bioscience Account Manager. The Bioscience Account Manager will be responsible for sales of Fujifilm’s Life Science Products.

This position will support the France/Italy/Spain markets. The ideal candidate will be based within the assigned territory. The role will support France, Greece, Italy, Malta, Portugal, Slovenia and Spain. 

We are hiring a Bioscience Account Manager. The Bioscience Account Manager will be responsible for sales of Fujifilm’s Life Science Products.

This position will support the Denmark market. The ideal candidate will be based within the assigned territory. The role will support Denmark, Finland, Sweden and Norway.

We are hiring a Bioscience Sales Manager. The Bioscience Sales Manager is responsible for managing the Bioscience Sales Team in their region for FujiFilm Life Science Products.

This position will support the United Kingdom, European, Middle East and Africa markets.

Summary:  The QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.

The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

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 direct supervision, the Laboratory Engineer I is responsible for assisting with the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical, and process development. Additional responsibilities include supporting the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. Basic pc troubleshooting and maintenance is a plus. This position may require support outside of normal business hours.

In this position, you will gain a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftMax PRO, and Unicorn.  The Laboratory Engineer I will maintain working knowledge for all such systems allowing for effective technical support. Additionally, a basic understanding of networking and Microsoft Active Directory is a plus.

The Senior Financial Business Partner provides strategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership, supporting all financial elements relating to revenue recognition accounting, contract review and approval and sales to program margin forecasting. This role is also responsible for ensuring financial goals are met and business strategies are effectively implemented. The role involves engaging with business partners to understand business processes, performance, highlighting risks and opportunities, and fostering well-informed decisions.

We are hiring a Sr. Product Mgr. Custom Media and Process Liquids. The Sr. Product Mgr. Custom Media and Process Liquids is responsible for managing the BP LVL&P product line portfolio within FISI LSBU. They will plan and execute product line strategy and tactics, coordinate relevant R&D, commercial, marketing, operational, and tactical initiatives to achieve product line performance goals, and act as product line champion internally and externally to FujiFilm.

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 Specialist 2, MES & DCS performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to DeltaV Distributed Control Systems (DCS) and Manufacturing Execution System (MES). The manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation.