Merck
Rahway, NJ
Shift: Full time
Job Description The Biologics Process Research Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company s biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms. This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be responsible for leading the design of the Manufacturing Execution System (MES)/ Electronic Batch Record (EBR) system with the process operations team, providing automation support during facility start-up activities, continued support of systems after start-up, and actively contribute to continuous improvement projects. Job Responsibilities: Provide key automation support for various manufacturing systems such as DCS (DeltaV), PLC, MES, SCADA and OEM systems Work with process development teams on technical development and the testing of new technologies, trialing new automation strategies, and implementing them in the GMP areas Support capital projects, work to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off shift work may be required to meet project, operations, and qualification needs. Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams. Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES/EBR, Quality, and Batch Reporting applications. Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements. Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P IDs, and System Life Cycle documentation Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP Lead automation related investigations into deviations and implement the corrective actions Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed Required Education, Experience and Skills: Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 4 years relevant experience, or a master’s degree with minimum years of relevant experience. Administration experience with MES/EBR platforms, such as Syncade, PAS-X, or similardo. Preferred Experience and Skills: At least 4 years of experience in an Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industries Proven experience with development and implementation of industrial controls such as DCS (Delta V), SCADA (Wonderware, iFix), PLC applications (Siemens, Allen Bradley), Historian (PI) I/O Networking experience (i.e. Ethernet/IP, OPC, Profinet, ControlNet, Profinet, DeviceNet, and ModBus protocols) is advantageous Working experience with GAMP, S88 and other industry standards. Commissioning and qualification test protocol development and execution Track record of working effectively with team-members of skill sets and backgrounds Strong presentations and verbal/written communication skills Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S E regulations as it pertains to biologics development Excellent attention to detail, highly independent with initiative Excellent troubleshooting and problem-solving skills Abi