II. Key Responsibilities * The process technologist/engineer is the primary expert in the enzymatic reaction as well as the unit operations for the production of Amoxicillin Trihydrate via enzymatic route; analyzes the involved variables to optimize and define operational parameters according to the operating strategy to achieve expected process yields. * Expert in quality-related topics involving the production line, follows up to complete on time and form key quality indicators such as complaint and deviation investigations, action plans from internal and external audits, and updating of operating procedures; analyzes and proposes improvements to ensure data integrity, change controls, and quality risk assessments. * Ensures that the technology and equipment used in the processes comply with regulations and that new technologies in the manufacturing process have a positive and significant impact in environmental terms and/or reduction of operational costs. * Analyzes, innovates, and implements strategies in procedures, equipment, and facilities to ensure optimization and improvement of processes without impacting PT quality. * Analyzes product losses during operation to implement comprehensive strategies that eliminate losses. * Works closely with the MS\&T team on improvement projects and analysis of residuals from the enzymatic process. * Analyzes the risk of impact of process variables on PT quality for the development of new improvement strategies in compliance with change control procedures. * Conducts training for personnel on new procedures defined in the process, derived from optimization proposals for raw materials, equipment, and operation control systems. * Responsible for ensuring compliance with quality indicators applicable to the production line (Deviations, Complaints, CAPAs, MoC actions, QRA actions, Procedures, Internal/External audits). * Responsible for analyzing and implementing improvements to ensure, together with management, the achievement of budgeted yields for enzymatic Amoxicillin. * Establishes action plans to correct and prevent recurrence of observations and/or deviations, as well as timely closure of these in accordance with quality procedures. * Provides support during quality and safety audits, ensuring that all CIP actions are fully and timely closed. * Supports the annual product review (APR) by providing statistical data on the processes. * Supports the implementation of company objectives through a concrete action plan and ensures their execution. * Drives and promotes continuous improvement of operations and provides support to the continuous improvement team. * Defines process parameters and operating procedures, and documents them into production operations and work instructions. * Analyzes and reports on the performance of the manufacturing process, as well as trend analysis of critical and non-critical process parameters defined in procedures. * Serves as the primary contact with MS\&T. **Requirements:** * Knowledge of regulations applicable to pharmaceutical chemicals, quality, enzymatic technology, chemistry, and safety aspects; must have the ability to influence and create a collaborative environment * Passion for process improvement, organized, creative, and able to work under pressure * Teamwork skills, ability to deliver training, good negotiator * Skills in trend analysis using statistical software (Minitab), project management, and advanced writing and executive reporting skills * Leadership and effective communication, promoter of company values * English proficiency desirable at 60\-80% * Background in Chemistry, Chemical Engineering, Biotechnology, or Biochemistry preferred * A master's degree related to Chemistry is desirable * Knowledge/experience in unit operations for product conditioning, classified areas, ISO8, clean rooms