The successful candidate will join 3PBiovian as a Technical Services Technician.
Main responsibilities:
* Responsible for the execution of the Tech Transfer Policies of the department according to the in-force SOPs.
* Responsible for the design of process scale-up according to the in-force SOPs.
* Responsible for the execution of the Validation activities in agreement with the in-force SOPs.
Specifically:
* 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.
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 reduced workday 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 a Learning & Development department, which 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 workspaces.
* 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.
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