Descripción de la oferta
Descripción del trabajo Are you looking for an opportunity to develop your professional career in a CDMO Manufacturing Operations Department? ¿Listo para inscribirse? Antes de hacerlo, asegúrese de leer todos los detalles pertenecientes a este trabajo en la descripción a continuación. The successful candidate will join 3PBiovian as a DSP Manufacturing Technician (Downstream Processing).
Responsibilities
Achieve the objectives set by the Team Leader and the DSP manufacturing manager.
Prepare, control and develop processes for the production of recombinant proteins, monoclonal antibodies or similar biological molecules in microorganisms.
Comply with good manufacturing practice (GMP), as well as occupational health and safety standards.
Maintain equipment and facilities in perfect state of repair, ensuring that they are operated according to the manuals provided by the manufacturer.
Conduct and/or supervise chromatographic runs, as well as all other manufacturing operations.
Ensure that the necessary material orders are scheduled in the SAP system to meet the production schedule according to the project and the weekly production plan.
Carry out the control and supervision, the stock of materials needed to perform the daily activities.
Prepare, pack, evaluate and unpack chromatography columns, as well as supervise these operations performed by Operators.
Program chromatography methods in UNICORN to ensure the correct execution of DSP processes.
Prepare and ensure the correct preparation of solutions required for the performance of manufacturing activities.
Participate in internal / external audits as required by the Quality Assurance Department.
Participate in the correct transfer of technologies and resources between companies related to 3P Biopharmaceuticals in collaboration with other departments and your manager.
Documentary responsibilities
Perform the incoming documentation of new equipment from the Scaling and Manufacturing DSP area under the supervision of the Team Leader DSP (FAB).
Ensure the maintenance of up to date technical documentation of the DSP process, as well as all documentation related to assigned tasks.
Record and manage any quality indicators associated with a scaling and manufacturing process. Participate in the investigation of the same together with the Team Leader DSP (FAB).
Oversee and write SOPs that correspond to the activities carried out in the Scaling and Manufacturing DSP department.
Prepare the documentation related to the quality system associated with the DSP Scale-up and Manufacturing plant: Deviations, Change Controls, Action Plans, Corrective, preventive and improvement actions, etc.
Education
Advanced Vocational Training or equivalent in related areas (Biology, Biochemistry, Biotechnology, Chemistry, Health, Clinical Laboratory, etc.).
University Degree or equivalent in related areas (Biology; Biochemistry; Biotechnology; Chemistry; IPPA; Chemical Engineering, etc.).
Master's Degree in related areas (Biology; Biochemistry; Biotechnology; Chemistry; IPPA, etc.) is valued but not required.
Languages
Fluent in Spanish.
Intermediate level of English (Level B2 / First Certificate).
Experience
Between 1 and 2 years of experience in/with:
GMP/GLP regulations
Chromatographic equipment
Packed chromatographic columns
Experience with ÄKTA
Experience with Unicorn
Other requirements
Open to work in shifts.
Office Software Package: User Level.
Unicorn Software Package: User Level.
Why 3PBiovian?
A permanent and stable position in a competitive growing company.
A competitive time off package with 41 paid days of vacation.
Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income taxes (childcare, health insurance, academic training etc.).
Company benefits club, which allows 3P Biovian employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, FNAC, Rituals, El Corte Inglés etc.).
All new hires who reside outside 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.
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