SENIOR PRODUCTION SPECIALIST (OPEN)

Tensive is a biomedical startup developing innovative prostheses aiming to offer a natural breast reconstruction or augmentation to improve patients’ quality of life. The production team is seeking a Senior Production Specialist (SPS) to support production and quality control activities. We love to hire collaborative people with a passion for learning and a teamwork spirit. Our team invests heavily in coaching new hires. Responsibilities Evaluates, recommends, and implements lean and root-cause-analysis-based measures, which result in continuous improvement in production methods, equipment performance, product quality, integrity, and efficiency; Collaborates with the Production Manager to draft periodic analysis reports, showing the production outputs and statistics; Shares with the production team his knowledge and experience, contributing to raising the technical training level of the team, especially those related to production steps including synthesis of polymeric precursors and processing of thereof; Performs manufacturing activities in ISO 7 cleanroom for Class III medical devices; Performs quality control tests on the production intermediates and the final product according to the internal procedures and applicable standards; Participates in the management of non-conformities, including drafting of the appropriate reports, investigation of root causes, implementation of preventive and corrective actions, and drafting related documents; Designs, executes, and reports the results of tests for validation of the manufacturing process; Performs installation qualification, operation qualification, and performance qualification of equipment involved in production; Participates in the monitoring of the environmental conditions and parameters of the cleanroom; Performs ordinary and extraordinary maintenance of equipment; Performs cleaning of the equipment and cleanroom; Fills and updates production templates, records registries, and documentation; Drafts and updates the Standard Operating Procedures (SOPs) and operating instructions (WIs) of the company’s production process; Verifies the state of maintenance and calibration of production equipment; Checks the maintenance and calibration status of instruments used in production; Requirements Previous work experience in producing Class III medical devices or in the pharmaceutical field and knowledge of quality management systems; Bachelor’s degree in chemistry, pharmaceutical science, or similar technical disciplines; Experience and skills in organic chemistry synthesis, on a scale of 5-10kg/synthesis; At least 3 years of experience in process upscaling and design of manufacturing systems; The candidate must be willing to work in a controlled cleanroom environment, which involves the wearing of relevant clothing and personal protective equipment; The candidate must be willing to work on a 2-shift basis; Knowledge of organizational, operational, and technical aspects of the production of medical devices or pharmaceutical products; Good knowledge of the English language, spoken and written; Good knowledge of the Microsoft Office package. #J-18808-Ljbffr