Cell Culture Process Specialist
hace 2 días
León
Job Description: We are seeking a highly skilled and motivated individual to join our team as a Cell Culture Process Specialist. As a key member of our production department, you will be responsible for executing UpStream (USP) activities in the cell culture area, ensuring that all operations are carried out in accordance with operational procedures and GMP regulations. **Key Responsibilities: • Execute cell culture activities according to process specifications and quality standards., • Write SOPs related to equipment and activities of the USP department., • Prepare production equipment prior to its use and after it (cleaning, inactivation, etc.)., • Register all productive activities in logbooks, batch records (BRs) or other documents, according to Company quality procedures., • Prepare culture means and process, filtering and sterilization solutions., • Provide support in preparation activities, reconditioning and materials sterilization., • Install and qualify equipment and support its maintenance, calibration and requalification., • Participate and promote improvements in productive processes, records and activities of the Company, encouraging continuous improvement., • Provide information and support in researches related to quality deviations and participate in the follow up of subsequent implementation of corrective and preventive measures. Required Skills and Qualifications: We are looking for individuals who possess the following skills and qualifications: • Degree in Pharmacy or similar., • Fluent Spanish and English, knowledge of other languages will be an asset., • +2 years of experience in a similar position., • Specific Knowledge: USP activities, GMP and SHE regulations. Benefits: We offer a dynamic work environment, competitive salary and benefits package, opportunities for professional growth and development, and a commitment to equality and diversity in the workplace. **Others: We strive to create a positive and inclusive work environment where everyone feels valued and respected. We believe in equal opportunities for all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.