We are seeking a Sr. R & D Technical Writer who will be responsible for preparing technical documentation to support IVD design history files and regulatory submissions.  Strong understanding of Quality Management Systems and Global IVD Regulations (including but not limited to IVDR and 21CFR820).driven and results-oriented Validation Engineer I to be responsible for assuring the successful execution of Werfen’s Validation Program. If you are interested in joining an organization where your talents and expertise will be highly appreciated, and if you meet our qualifications to excel in this position, we want to hear from you. Contact us today!

Job Summary   Provides analytics and business intelligence insights to enable the North America Commercial Operations leadership team to make informed strategic decisions that drive revenue. The role will act as a consultant to Senior Leadership of Commercial Operations with a focus on reporting, analytics and fostering strong relationships with business partners (eg. Sales, finance, IT). He/she will be looked upon to gather data and perform ad-hoc analyses for the business, develop insights that drive actions and draw upon experience to identify new areas for growth or improvement.

Position Summary: Performs formulations of Clinical Chemistry, Co-Oximeter, and/or Coagulation controls and reagents using various automated and manual techniques. Formulations are to be performed in accordance with established Quality Standards and GMP requirements

Overview:   To learn the importance of employment law and compliance and to understand the day-to-day operations of an efficient Human Resources Department.

We are seeking a Solid Phase Technician to join our manufacturing team. As a Solid Phase Technician you will perform a variety of tasks associated with the manufacturing operations of solid phase plates for Werfen products. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!   This position is not eligible for...

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Job Summary   Autoimmunity Sr. Managers are responsible for managing the overall operations, business results and performance for their assigned department(s). Responsible for department functional plans, determining current and future position profiles and staffing needs, proposing and managing department budgets, performance metrics and reporting, analyzing operations to identify gaps, ensure compliance, safety, and ongoing process improvements, as well as leading and developing lower-level management staff and high performing teams.  

Job Summary   As an Associate Service Center Technician, you will engage in routine mechanical, electromechanical, and electronic technical activities related to servicing returned instruments. Your role will require attention to detail during troubleshooting, repairs, and documentation of these activities. You will work collaboratively with other technicians and cross-functional partners, maintaining a sense of urgency and precision to ensure a high level of customer satisfaction.  

A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards

We are looking to hire a Biologics Procurement Manager who will manage all tasks and functions associated with Biologics Procurement and Manufacturing Training. This includes managing the supply of red blood cells and other blood products needed for Werfen's Red Cell and Capture product line. This person will also manage activities associated with training new employees and cross-training or re-training current employees as needed for Red Cell Processing, Monoclonal Production, Production Support, Controlled Components, Solid Phase, Vialing and Packaging. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply...

Job Summary The Assay Development Scientist III Performs a variety of tasks, including supervisory activities, associated with the development of new products and new manufacturing process-es, the investigation into and implementation of product and process changes, and the transfer of new products and processes to the manufacturing departments. Oversees and provides leadership to cross functional development team in developing new products using Design Controls. Works at strategic and tactical levels by participating in identifying resources for the department including facility, equipment, personnel, and budgetary...

Job Summary The Assay Development Scientist III Performs a variety of tasks, including supervisory activities, associated with the development of new products and new manufacturing process-es, the investigation into and implementation of product and process changes, and the transfer of new products and processes to the manufacturing departments. Oversees and provides leadership to cross functional development team in developing new products using Design Controls. Works at strategic and tactical levels by participating in identifying resources for the department including facility, equipment, personnel, and budgetary...

The Quality Systems (QS) Specialist I is responsible forassisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS

Werfen   Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories...

Position Summary:   Responsible for ensuring total customer satisfaction within the Werfen installed base.  Preform installations, validations/verification and training on Werfen analyzers.  Provide on-going clinical support, customer education and consult with customers regarding matters of regulatory requirements and compliance. 

Position Summary:   This position is responsible for the successful implementation of Werfen’s data management solution(s) for new and existing Werfen customers in collaboration with the IT Solutions Architect.  This includes, but is not limited to, completion of all required post sale technical implementation activities, ensuring the product application/solution functions to specifications.  Ensures customer satisfaction during the installation, validation, integration and go-live processes.

Job Summary:   The Director of Sales, Business Unit is responsible for national sales, budgeting, and expenses management within Werfen's North American Commercial Operations for their assigned Business Unit. In this high-level leadership position, the Business Unit Director will influence, develop, and implement long-term strategies and key performance indicators. This role requires high levels of collaboration with internal customers as well as field-based...

Job Summary Responsible for the strategic planning for the assay development and product development teams to align with corporate objectives. This position will lead the discovery, design, development, and optimization of diagnostic products and assays for our IVD product portfolio. This role will oversee teams to drive innovation in transfusion diagnostics to meet clinical needs and regulatory requirements.

Job Summary We are seeking a skilled and security-conscious Cloud Engineer to join our dynamic Cybersecurity team. This role is pivotal in designing, deploying, and maintaining our secure cloud infrastructure, with a primary focus on Microsoft Azure and the M365 ecosystem. You will be responsible for translating security requirements into tangible technical controls, ensuring our cloud services are resilient, compliant, and hardened against modern threats. This position directly adds value by enhancing the organization's security posture and enabling the business to leverage cloud technologies safely and efficiently. Your unique contribution will...

Position Summary:   Defines and implements market requirements for new products. Product management of a dedicated product line. Prepares marketing support program for a specific product, product line, or product area. Coordinates implementation with technical services and field sales organization. Provides Marketing assistance to field personnel and customers.