Process Engineer
Current• Support the development, transfer and validation of manufacturing processes, including cleaning validation.• Ensure quality standards and best practices are maintained throughout the transfer process.• Develop, author and maintain documents that support the various steps necessary in transferring products. • Provide routine process technical support and troubleshooting for resolution of manufacturing issues.• Provide technical training on process and/or equipment as required.• Act as assigned technical lead and owner of manufacturing process systems.• Develop and maintain productive links with process technology suppliers and vendors.• Lead/represent Technical Operations on project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle while ensuring overall project objectives of scope and schedule are adhered to.• Participate in project teams for various new equipment needed in support of manufacturing activities.• Anticipate potential process related problems, risks and technical conflicts and develop the necessary contingency plans that optimize business continuity.• Ensure work activities are conducted in strict accordance with safety guidelines and processing standard cGMP's and SOP's.