Process Engineer/Process Technologist

Description

Position Summary: Expert Process Technologist/Engineer specializing in optimization of enzymatic operations, quality, and regulatory compliance for Amoxicillin manufacturing. Key Highlights: 1. Expert in enzymatic reaction and unit operations. 2. Quality leader, ensuring compliance and continuous improvement. 3. Drives process optimization and technological innovation. **II. Key Responsibilities** * The Process Technologist/Engineer is the primary expert on enzymatic reaction as well as unit operations for the enzymatic production of Amoxicillin Trihydrate; analyzes involved variables to optimize and define operational parameters in accordance with the operating strategy to achieve expected process yields. * Expert in quality-related topics involving the production line; follows up to complete key quality indicators on time and in full, such as complaint and deviation investigations, action plans from internal and external audits, and updates to operating procedures; analyzes and proposes improvements to ensure data integrity, change controls, and quality risk analysis. * Ensures that technologies and equipment used in processes comply with regulations and that new technologies implemented in the manufacturing process deliver a positive and significant impact in terms of environmental performance and/or reduction of operational costs. * Analyzes, innovates, and implements strategies related to procedures, equipment, and facilities to ensure process optimization and improvement without impacting finished product (PT) quality. * Analyzes product losses during operations to implement comprehensive strategies eliminating such losses. * Collaborates with the MS\&T team on improvement projects and analysis of residuals from the enzymatic process. * Analyzes the risk of process variable impact on PT quality to develop new improvement strategies in compliance with change control procedures. * Conducts training for personnel on newly defined process procedures resulting from optimization proposals for raw materials, equipment, and operational 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 jointly ensure, with Management, the budgeted yields for enzymatic Amoxicillin. * Establishes action plans to correct and prevent recurrence of observations and/or deviations, and ensures their timely closure per quality procedures. * Supports quality and safety audits, ensuring all CIP actions are fully closed within the defined timeframe. * Supports the Annual Product Review (APR) by providing statistical data on processes. * Supports implementation of corporate objectives through a concrete action plan and ensures its execution. * Generates and promotes continuous improvement of operations and supports the continuous improvement team. * Defines process parameters and operating procedures, and documents them in production operations and work instructions. * Analyzes and reports manufacturing process performance, 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 possess ability to influence and foster a collaborative environment. * Passion for process improvement, organized, creative, and capable of working under pressure. * Team player, skilled at delivering training, strong negotiator. * Proficient in trend analysis using statistical software packages (e.g., Minitab), project management, and advanced executive writing and reporting skills. * Leadership and effective communication; champion of company values. * English proficiency desirable: 60\-80%. * Relevant academic background in Chemistry, Chemical Engineering, Biotechnology, or Biochemistry. * Master’s degree related to Chemistry is desirable. * Knowledge/Experience in unit operations for product conditioning, classified areas, ISO8, cleanrooms.