Technical Support Scientist II

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 also develop clinical software applications and laboratory instrumentation systems enhancing patient care.

We operate directly in 30 countries, and in more than 100 territories through distributors. Our headquarters and technology centers are located in Europe and the United States, and our workforce is more than 7,000 strong.

In Werfen, our purpose is to contribute to the advancement of patient care around the world through innovative specialized diagnostics solutions. 

Job Summary

Responsible of the assigned Projects and coordinates a multidisciplinary team when the project requires it. Manage the projects of the designed area of products. Provide specialized technical assistance in the different areas of production, research and development and quality control to guaranty the correct performance of products, to implement process improvements within the quality specifications and to support product transfer from R&D to production department. The position requires a degree of coordination and communication between the individual and the project team members including vendors and customers.

Key Accountabilities

• Coordinate the preparation and execution of the Technical Support plans for each assigned project.

• Prepare the documentation to support the activities in order to fulfill both the Technical Support plan and Quality Assurance requirements (i.e Risk Analysis, Verification, Validation, etc.

• Plan and coordinate the activities of the Biokit multidisciplinary group involved in each project.

• Plan and coordinate the activities of the external group involved in each project (customers, suppliers, external evaluations, etc.).

• Evaluate obtained results in accordance with the protocols specifications, procedures or product requirements.

• Redesign the project plan based on the results obtained or the Quality Assurance requirements.

• Periodically communicates problems, and progress to his/her supervisor.

• Occasionally communicates status updates and results across the organization.

• Supervises the selection of appropriate experimental and analytical methods and define protocols.

• Schedules own and team activities in accordance with assignments and helps to set priorities.

• Supervises the coordination of the scheduling of laboratory testing.

• Be responsible of the location of all the documentation generated in each project.

• Review new R&D manufacturing procedures in order to identify critical points and the usefulness of the in-process controls.

• Review the processes of transfer of products from R&D to production, facilitating and providing the know-how of both sides in the implementation of the pilot scale to production scale.

• Prepare the documentation to support the activities derived from NC, CAPA, RCI.

Networking/Key relationships

This profile interacts with following roles:

• Manufacturing Sections plus Quality Control.

• Research & Development (R&D)

• Quality Operations, Quality validations, Quality Design, Supplier Quality, market surveillance, Regulatory Affairs ans Quality Systems.

• Supply Chain (planning, procurement and Warehouse)

• IT Systems

• Engineering & maintenance amd facilities services

• Operational Excellence

Minimum Knowledge & Experience required for the position:

Education:

• Required: Bachelor’s degree (Grado) in the biological or related sciences
• Degree may be substituted by relevant skills and work experience
• Valuable: Any additional degree higher than that required.

Experience:

• Required: 4 years in similar position.

Additional Skills/Knowledge:

• Software:Fluency in office tools (Excel & Word), Valuable Basic Knowledge in SAP.
• Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).
• Standards: Valuable knowledge on Biotechnology, ISO, GMP’s, FDA rules and Lean environments. 

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and competencies:

• Methodical and well-organized person
• Teamwork
• Time-management skills
• Attention to detail and accuracy.
• Able to use and apply scientific principles, theories, and concepts.
• Teamwork and interpersonal skills. Flexibility to work with and provide support for a number of people.
• Oral and written communication skills.
• Familiarity with quality standards as required.
• Troubleshooting abilities required.
• Ability to adapt to Technical Support flexible and changing environment.
• Ability to work under pressure.
• Ability to collaborate, participate and coordinate actively with working groups
• Reflects values of Werfen in the quality of work and working relationships.

Travel requirements:

Able to do short travels if job required.

Individual Contributor Core Competencies:

Managing Work
Emotional Intelligence Essentials
Building Partnerships
Decision Making
Continuous Improvement
Continuous Learning