Sr Engineer II - Clinical Label and Pack

About This RoleAs a Sr. Engineer II at our Research Triangle Park (RTP) facility, you will be essential to our Labeling and Packaging operations for bottles, vials, blisters, and syringes, playing a key role in delivering life-changing therapies to patients. This position offers a unique chance to engage in both the startup and ongoing operations phases, providing a well-rounded experience in pharmaceutical engineering.The Sr. Engineer II designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process and facility equipment. The incumbent would support technology transfer of new processes into the facility, provide project engineering support as required for new equipment installations and modifications to existing equipment and have the ability to manage medium to large engineering projects with little direction. In addition, they would develop validation protocols, oversee validation testing and final report approvals. This role will work with and provide some direction to contractors and participate in and lead multi-function teams to implement change and improvements on existing processes.What You’ll DoResponsible for supporting manufacturing operations by troubleshooting process equipment system issues and identifying improvements. Update preventative maintenance job plans, equipment standards, drawings and specifications as necessary.Provide engineering technical support and troubleshooting for plant utilities and facilities systems. Participate in multi-functional teams to implement changes and improve on existing processesProvide responsible engineering and validation support for process and utility systems. Specifically design and develop validation protocols, provide expertise to associated equipment and automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.Identify and lead process equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and area efforts, provide technical evaluations of process equipment including validation requirements for change controls and associated action plans.Provide support with presenting discussion topics during health authority (e.g. – FDA) and partner inspections with regards to engineering and validation practices and policies.Who You AreYou are an experienced equipment engineer who likes to troubleshoot and investigate improvements to increase site operations and passionate about learning new technologies and working in a cross-functional environment. You are accountable for achieving milestones in equipment projects and are passionate about making a difference and have a strong desire to contribute to a mission-driven organization. You thrive in a fast-paced environment and are eager to learn and grow. Your adaptability and attention to detail make you a valuable team player in the complex field of biomanufacturing.