3PBIOVIAN Noáin, Chartered Community of Navarre, Spain
The successful candidate will join 3PBiovian as a Technical Services Technician.
Responsibilities:
* Responsible for the execution of the Tech Transfer Policies of the department according to the in-force SOP’s.
* Responsible for the design of process scale up according to the in-force SOP’s.
* Responsible for 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.
Minimum Requirements:
* 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.
Benefits:
* 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.
* Flexible working hours during the week and a reduced workday on Friday of 7h.
* Special Summer working day of 7h during July and August.
* Learning & Development department creating personalized career plans for employees.
* Focus on internal talent, upskilling, and reskilling opportunities.
* Participation in solidarity events such as charity races, social donations.
* Programs aimed at improving the physical, psychological, and emotional well-being of employees.
* High-impact work environment with flat hierarchies and short decision-making processes.
* Relocation service and/or assistance for new hires residing outside of Navarra.
We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr