Biotech Tech Transfer & Validation Expert

JobLookup; Nava; Presencial; EUR 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

26 paid days off

Flexible compensation plan

Relocation assistance

Employee benefits club

Flexible working hours

Descripción de la vacante

3PBiovian is seeking a Technical Services Technician to join our Technical Services Team in Spain. You will drive tech transfer activities, scale-up design, and validation tasks within a Biotech manufacturing context.

The role requires a science-based degree and at least five years in tech transfer and process validation, with strong GMP knowledge and risk analysis experience (HAZOP/FMEA). You will prepare protocols, coordinate campaigns, and ensure regulatory compliance.

Formación

• Bachelor's degree in Science, Chemical Engineering, or related discipline.
• 5 years of experience in tech transfer activities of Biological processes.
• At least 5 years of experience in process validation and cleaning validation activities.
• Experience in risk analysis and HAZOP/FMEA methodologies.
• Expert in GMP regulations.

Responsabilidades

• Execute Tech Transfer policies per SOPs.
• Design process scale-up according to SOPs.
• Execute Validation activities per SOPs.
• Prepare and execute Cleaning, Process and Analytical Validation Protocols.
• Coordinate the validation campaigns and tech transfer runs.
• Lead risk analysis sessions using HAZOP/FMEA.
• Prepare URS for equipment and ensure proper documentation.
• Ensure GMP compliance across activities.

Conocimientos

Tech transfer

Biotech processes

Process validation

GMP compliance

HAZOP/FMEA

Educación

Bachelor's degree in Science or related

Descripción del empleo

3PBiovian is seeking a Technical Services Technician to join our Technical Services Team in Spain. You will drive tech transfer activities, scale-up design, and validation tasks within a Biotech manufacturing context.

The role requires a science-based degree and at least five years in tech transfer and process validation, with strong GMP knowledge and risk analysis experience (HAZOP/FMEA). You will prepare protocols, coordinate campaigns, and ensure regulatory compliance.