Technical Services Technician (MSAT)

3PBIOVIAN; Navarra; Presencial; EUR 45.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

26 paid days off

Flexible compensation plan

Relocation assistance

Learning & Development

Career growth opportunities

Descripción de la vacante

3PBIOVIAN in Navarra is seeking a Technical Services Technician to join the Technical Services Team, driving tech transfer activities and process scale-up in a biotech setting. You will design and execute validation and cleaning validation protocols, coordinate validation campaigns, and ensure GMP compliance across departments.

Fluency in English is required; a science or chemical engineering degree with 5+ years in tech transfer and validation is expected.

Formación

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

Responsabilidades

• Execute Tech Transfer policies per SOPs and design process scale-up.
• Perform validation activities in line with SOPs.
• Prepare and execute validation protocols for Tech Transfer.
• Follow Tech Transfer runs and scale-up batches and prepare reports.
• Coordinate validation campaigns and lead risk analysis sessions.

Conocimientos

Tech Transfer Experience

GMP Knowledge

English Proficiency

Educación

Bachelor’s degree in Science/Engineering

Descripción del empleo

We are looking for a Technical Services Technician to join our Technical Services Team.

?Main Responsibilities:

As Technical Services Technician , your responsibilities will include:

• Responsible of the execution of the Tech Transfer Policies of the department according to the in-force SOP’s.

• Responsible of design of process scale up according to the in-force SOP’s.

• Responsible of the execution of the Validation activities in agreement with the in-force SOP’s.

• 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.

• Evaluate the technical documentation of the potential processes to be transferred.

• 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.

• Prepare and execute Cleaning, Process and Analytical Validation Protocols.

• Coordinate the execution of the Validation Campaigns.

• Lead the risk analysis sessions following HAZOP/FMEA methodologies.

• 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.

• Comply and assure the compliance of the GMP regulations.

Assessment Criteria:

• Bachelor’s degree in Science, Chemical Engineering, or any other related discipline is required.

• 5 years of experience in tech transfer activities of Biological processes, internal and external tech transfer.

• At least 5 years of experience in process validation and cleaning validation activities, desirable in a biotech company.

• Experience in risk analysis and HAZOP/FMEA methodologies.

• Expert in GMP regulations.

• Fluent in English

Why 3PBiovian?

• You will have 26 paid days off: 23 vacation days + 2 personal days + 1 day off set by the company.

• 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.).

• Company benefits club, which allows 3P employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, Fnac, Rituals, El Corte Inglés, etc.).

• Flexible working hours during the week and a reduce work day on Friday of 7h.

• Special Summer working day of 7h during July and August.

• 3PBio is committed to the continuous, updated and personalized improvement of our personnel’s learning. To this end, we have Learning & Development department, who is in charge of creating personalized, individualized and differentiating career plans for our employees.

• The company continues to focus on internal talent and stable employment, focusing on upskilling and reskilling. We offer opportunities for professional growth and take an environment of trust.

• We encourage the participation of our employees in solidarity events such as charity races, social donations...

• We have several programs aimed at improving the physical, psychological and emotional well-being of our employees. In this context, we participate in the Corporate Challenge, promote healthy lunches and comfortable and safe work spaces.

• We have a high-impact work environment with flat hierarchies and short decision-making processes.

• All new hires who reside outside of Navarra are provided with a relocation service and/or assistance.

Why us?

We know it takes people with passion and a shared purpose to manufacture advanced medicines.

We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production. With a focus on biotechnology applications in both human an animal health sectors, we offer customized solutions that meet the specific needs of all our clients

From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies. We have what it takes to help you improve lives.

It's within us.