Technical Services Technician - (XJU-716)

3PBIOVIAN; País Vasco; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa innovadora en el sector biotecnológico busca un Técnico de Servicios Técnicos para unirse a su equipo. En esta emocionante posición, serás responsable de la ejecución de políticas de transferencia de tecnología y validación de procesos, asegurando el cumplimiento de las regulaciones GMP. Con un enfoque en el desarrollo continuo y el bienestar de los empleados, esta empresa ofrece un entorno de trabajo dinámico y oportunidades de crecimiento. Disfrutarás de un horario flexible, días libres pagados y un plan de compensación adaptable. Si tienes pasión por la biotecnología y quieres marcar la diferencia, esta es tu oportunidad.

Servicios

26 días de vacaciones pagadas

Plan de compensación flexible

Club de beneficios de la empresa

Horario flexible

Día de trabajo reducido los viernes

Compromiso con el aprendizaje continuo

Asistencia para reubicación

Formación

• 5 años de experiencia en actividades de transferencia de tecnología de procesos biológicos.
• Experiencia en validación de procesos y validación de limpieza en la industria biotecnológica.

Responsabilidades

• Ejecutar políticas de transferencia de tecnología y validar procesos según SOP.
• Coordinar campañas de validación y preparar informes de transferencia de tecnología.

Conocimientos

Transferencia de Tecnología

Validación de Procesos

Análisis de Riesgos

Regulaciones GMP

Educación

Licenciatura en Ciencias o Ingeniería Química

Descripción del empleo

The successful candidate will join 3PBiovian as a Technical Services Technician.

Main responsibilities:

1. Responsible for the execution of the Tech Transfer Policies of the department according to the in-force SOP’s.
2. Responsible for the design of process scale-up according to the in-force SOP’s.
3. Responsible for the execution of the Validation activities in agreement with the in-force SOP’s.
4. Prepare and execute the protocols corresponding to the Tech Transfer policies in a Biotech industry, not only from customer to facility but also among departments.
5. Evaluate the technical documentation of the potential processes to be transferred.
6. Follow-up the Tech Transfer runs and Scale-Up batches in order to assure the right performance of these batches. Prepare the Tech Transfer report.
7. Prepare and execute Cleaning, Process and Analytical Validation Protocols.
8. Coordinate the execution of the Validation Campaigns.
9. Lead the risk analysis sessions following HAZOP / FMEA methodologies.
10. Prepare URS’s of the equipment needed for the execution of a certain project as well as the internal documentation for the right management of the equipment.
11. Comply and assure the compliance of the GMP regulations.

Assessment criteria:

1. Bachelor’s degree in Science, Chemical Engineering, or any other related discipline is required.
2. 5 years of experience in tech transfer activities of Biological processes, internal and external tech transfer.
3. At least 5 years of experience in process validation and cleaning validation activities, desirable in a biotech company.
4. Experience in risk analysis and HAZOP / FMEA methodologies.
5. Expert in GMP regulations.

Why 3PBiovian?

1. You will have 26 paid days off: 23 vacation days + 2 personal days + 1 day off set by the company.
2. Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income tax (childcare, health insurance, training, etc.).
3. Company benefits club, which allows 3P employees to obtain exclusive prices and discounts on a multitude of products and services.
4. Flexible working hours during the week and a reduced workday on Friday of 7h.
5. Special Summer working day of 7h during July and August.
6. 3PBio is committed to the continuous, updated and personalized improvement of our personnel's learning.
7. The company continues to focus on internal talent and stable employment, focusing on upskilling and reskilling.
8. We encourage the participation of our employees in solidarity events such as charity races, social donations.
9. We have several programs aimed at improving the physical, psychological and emotional well-being of our employees.
10. We have a high-impact work environment with flat hierarchies and short decision-making processes.
11. All new hires who reside outside of Navarra are provided with a relocation service and/or assistance.