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  • 3 weeks ago

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Roles & Responsibilities Job Description: We are seeking a Process Engineer with Project Management Experience. The ideal candidate will possess at least 5 to 7 years of technical expertise in process engineering coupled with exceptional project management skills in Pharma or medical device industry preferably. Proven experience in process engineering within a manufacturing environment, with a minimum of 5 years of relevant experience. At least 1 ~ 3 years of hands-on experience in cGMP and GDP as well as validation requirement, product development, technical troubleshooting is preferred. Demonstration of excellent written scientific communications skills. The successful candidate will play a crucial role in optimizing our manufacturing processes, improving efficiency, and ensuring quality standards are met. Key Responsibilities: Process Design and Optimization: Required technical expertise to assess current manufacturing processes, identify inefficiencies, and develop innovative... solutions to optimize manufacturing operations. Develop data-driven approaches to monitor key performance indicators, analyze trends, and identify areas for improvement. Develop actionable insights to drive decision-making and process optimization initiatives. Improve efficiency, quality, and cost reduction, ensuring continuous improvement for the smooth functioning of production lines. Develop new techniques, ability to modify existing designs and must collaborate for process improvement projects. Ability to create process flow diagrams, Piping and Instrumentation Diagrams and equipment specifications. Coordinate and oversee the planning and implementation of commissioning, installation qualification, and operational qualification processes. Review and prepare validation protocols and reports to ensure technical accuracy and adherence to standards. Develop or revise URS, FRS, SLIA, SDS, risk assessments, qualification test plans, and compile qualification documentation. Support in improvement projects, oversee the execution of process validations and equipment qualifications, and collaborate with relevant cross-functional teams. Prepare comprehensive documentation including standard operating procedures (SOPs), process flow diagrams, and technical reports to ensure clarity and consistency in processes. Provide technical training and support to operations teams to ensure successful implementation of new processes and technologies. Serve as a subject matter expert in process engineering principles and methodologies. Project Management Lead engineering projects and ability to work with cross-functional teams in the execution of process improvement projects from conception to completion. This includes defining project scope, establishing timelines, managing resources, and ensuring project objectives are achieved within budget and schedule constraints. Quality Assurance and Compliance Collaborate with quality assurance teams to develop and implement robust quality control measures, ensuring adherence to regulatory standards and product specifications. Enforce quality control protocols to guarantee products align with both regulatory mandates and customer expectations. Validate process adherence to safety guidelines and enact strategies to minimize potential hazards. Uphold meticulous records of procedures, encompassing SOPs, operational manuals, and project documentation. Generate routine progress updates and disseminate project statuses to stakeholders. Qualifications: Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field. If you are a driven and results-oriented Process Engineer looking for an opportunity to make a significant impact in a dynamic environment, we invite you to apply for this exciting position. Tell employers what skills you have Troubleshooting Process Improvement Quality Assurance Manufacturing Processes Process Engineering Piping Compliance Project Management Process Optimization Product Development Instrumentation Manufacturing Chemical Engineering Commissioning Mechanical Engineering


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