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DSP Operator
Indeed
Full-time
Onsite
No experience limit
No degree limit
C. 13, 26, 24192 León, Spain
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Description

Overview: At Mabxience, a company specialized in the development and manufacturing of biosimilar medicines, we are seeking a downstream operator for our facility in León (Spain). Responsibilities: **Overall responsibility** * Responsible for carrying out activities within the Downstream Purification production department, following standard operating procedures and GMP regulatory requirements. * Under the supervision of the Purification Supervisor and area technicians, responsible for performing specific departmental tasks including equipment preparation and execution of standardized production procedures under GMP standards as part of a work team. * Production operations within the department will include, among others, handling chromatographic resins and columns, use of conventional or tangential filtration systems, handling intermediate products, preparation of solutions and excipients, as well as equipment and material preparation. **Specific responsibilities** * Execute protein purification activities according to specifications from the Research and Development department and the company's quality standards.* Draft standard operating procedures (SOPs) related to equipment and activities within the department. * Draft batch record documents. * Prepare production equipment before and after use (cleaning, sanitization, etc.). * Record all production activities in logbooks, batch records (BRs), or other documents according to the Company's Quality guidelines and procedures. * Preparation of media, buffers, and process solutions, including their filtration and/or sterilization. * Support activities related to preparation, conditioning, and sterilization of production materials. * Participate in the installation and qualification of production equipment, as well as provide support in maintenance, calibration, and requalification. * Participate in and propose improvements to production processes, records, and company activities, promoting continuous improvement within the department. * Follow production schedules, training, and qualification programs. * Provide information and support during quality deviation investigations, and participate in implementing corrective and preventive action plans for each deviation. * Interact with equipment suppliers and routine production material providers. * Collaborate with other departments within the company, fostering a positive and cooperative work environment. * Perform necessary modifications and updates to Batch Records due to deviations, improvements, or other reasons. * Maintain environmentally responsible practices in compliance with the company's current regulations and requirements regarding safety, hygiene, and environmental protection. * Participate in assigned client project teams, attending meetings, teleconferences, and other related activities. Qualifications: **Requirements** * Education: Intermediate or advanced vocational training. A university degree will be valued. * Languages: Spanish and intermediate English. * Experience (years/areas): No prior experience required. Over 1 year of experience in laboratory or industrial production will be valued. * Specific knowledge: Basic knowledge of unit operations in separation processes.

Source:  indeed View original post
David Muñoz
Indeed · HR

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