•Lead process engineer for equipment and process transfer of new drug substance•Develop process equipment specifications and technical documentation for transferring of new drug substance process with the capabilities of scale up.•Design and space plan for new manufacturing and support spaces with emphasis on lean manufacturing during the concept and design phases.•Provide manufacturing optimization opportunities within the design phase for process simplification.•Conduct design… Show more •Lead process engineer for equipment and process transfer of new drug substance•Develop process equipment specifications and technical documentation for transferring of new drug substance process with the capabilities of scale up.•Design and space plan for new manufacturing and support spaces with emphasis on lean manufacturing during the concept and design phases.•Provide manufacturing optimization opportunities within the design phase for process simplification.•Conduct design of experiments and feasibility studies on prospective equipment.•Define and establish maintenance plans and spare part management for new process and support equipment.•Cross-collaborate with quality, regulatory, manufacturing, engineering and global R&D teams for the technical transfer and site start-up of new drug substance. Show less

•Subject Matter Expert for bulk vaccine Adjuvant, utilizing engineering methods to optimize and support manufacturing processes specific to process equipment and associated control systems. •Support manufacturing by being readily available to triage equipment malfunctions and provide efficient solutions to prevent downtime or loss of product.•Provide support to primary (bulk) vaccine adjuvant manufacturing by collecting and analyzing equipment performance data, performing FMEA… Show more •Subject Matter Expert for bulk vaccine Adjuvant, utilizing engineering methods to optimize and support manufacturing processes specific to process equipment and associated control systems. •Support manufacturing by being readily available to triage equipment malfunctions and provide efficient solutions to prevent downtime or loss of product.•Provide support to primary (bulk) vaccine adjuvant manufacturing by collecting and analyzing equipment performance data, performing FMEA, developing and implementing preventive maintenance and calibration programs to ensure a reliable and optimized operational capability. •Analyze repairs and maintenance requirements to proactively address equipment weaknesses. Troubleshoot and correct problems for process equipment and associated control systems. •Lead the design and installation of new manufacturing process equipment and associated control systems which are harmonized with the GSK standards.•Establish change controls, equipment requirement specifications, manufacturing procedures, and other documentation to support implementation of new or retrofitted equipment/processes.•Provide technical guidance and oversight to adjuvant electro-mechanical technicians.•Support validation efforts during full validation lifecycle for existing process changes and new automation implementation. Show less

•Alcon certified Six Sigma Green Belt•Support manufacturing to triage equipment malfunctions during processing to ensure timely resolution and reduce manufacturing downtime•Project lead/resource for assigned capital projects leading inception, design build, test and implementation. •Subject Matter Expert for assigned manufacturing processes, utilizing engineering methods to optimize manufacturing processes in product quality, process yield, and efficiency.•Subject Matter Expert… Show more •Alcon certified Six Sigma Green Belt•Support manufacturing to triage equipment malfunctions during processing to ensure timely resolution and reduce manufacturing downtime•Project lead/resource for assigned capital projects leading inception, design build, test and implementation. •Subject Matter Expert for assigned manufacturing processes, utilizing engineering methods to optimize manufacturing processes in product quality, process yield, and efficiency.•Subject Matter Expert for assigned manufacturing equipment including Automated/Semi-Automated processes.•Responsible for identifying, designing and implementing improvements to equipment and processes.•Supports validation team in development/execution of validation documentation Show less

•Supports product life-cycle through data collection and analysis, implementation and revision of product conformance standards, continuous process improvement, and reduction of reject levels.•Develop process improvement initiatives to increase operational efficiency and productivity.•Provide Quality Engineering support and guidance to assigned production areas and review/approve product, process, and/or document non-conformances.•Implement lean principles within the surgical… Show more •Supports product life-cycle through data collection and analysis, implementation and revision of product conformance standards, continuous process improvement, and reduction of reject levels.•Develop process improvement initiatives to increase operational efficiency and productivity.•Provide Quality Engineering support and guidance to assigned production areas and review/approve product, process, and/or document non-conformances.•Implement lean principles within the surgical manufacturing department to improve product and process work flow.•Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters within the surgical line.•Investigate and/or provide guidance and approval for non-conformance events and Corrective Actions and Preventive Actions. Show less

•Design and develop lighting, power, communication, and security systems while maintaining budget, quality work, and adhering to the latest industry design standards and best practices.•Perform electrical calculations for loads, cable sizing, voltage drop, and lighting illuminations to assist in developing low-voltage electrical systems for expansions of facilities while following NEC & IECC codes. •Survey site conditions to document existing electrical services and equipment for new… Show more •Design and develop lighting, power, communication, and security systems while maintaining budget, quality work, and adhering to the latest industry design standards and best practices.•Perform electrical calculations for loads, cable sizing, voltage drop, and lighting illuminations to assist in developing low-voltage electrical systems for expansions of facilities while following NEC & IECC codes. •Survey site conditions to document existing electrical services and equipment for new fit-outs.•Confer with clients, vendors and management personnel regarding purchases, procedures, product specifications, manufacturing capabilities and project status. Show less