Job DescriptionThe Biologics Innovation Xceleration facility, at Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The Senior Automation Engineer will provide dedicated automation support, implementation of process control and troubleshooting in compliance with cGMPs for various manufacturing systems within our biotechnology facility and actively contribute to continuous improvement projects for the development and clinical manufacturing of biologics as part of the Process Automation team in the Enabling Technology and Engineering Department.The Process Automation team will provide a strategic link between our early and late-stage pipeline and will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.Key responsibilities will include: Provide key automation support for various manufacturing systems such as DCS, PLC, and OEM systems providing Intensified Fed Batch and Continuous Manufacturing within a facility operating a “Lights-Out” concept. 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 standards. Implement Continuous Improvement projects of automation processes including review of equipment specifications, P&IDs, and System Life Cycle documentation. Transfer of Process Technologies from early-stage pipeline facilities and drive to GMP Operational Status, and support line of sight to commercial supply. Lead automation related investigations and implementation of corrective actions. Supporting the qualification of new systems. Write, review, and/or execute test documents. Maintain automation systems to GxP compliant state and audit readiness. Collaborates within the Operations, Quality, Validation and Technical organizations to resolve complex problems and meet project, operations, and qualification needs. Support and Enable the Transfer of process Technologies from early-stage pipeline facilities to GMP Operational status to commercial supply.Actively supports Digital Transformation initiatives involving system integrations, data connectivity, data analysis/modelling, validation methods and value-based optimization of manufacturing.Actively demonstrate the core culture values and behaviours within the process Automation team (empowerment, diversity and inclusion, accountability, trust, open communication). Top of FormYour profileBachelor’s degree in a Life Science discipline or equivalent practical experience in automation control systems.Minimum 5 years’ experience in an Automation Engineering function within Biologics, Pharmaceutical, Medical Devices, or Food industries.Demonstratable experience with development and implementation of industrial controls such as DCS (Delta V), PLC applications (Siemens, Allen Bradley), Historian (PI).Experience with DeltaV Batch, including the ISA S95 and S88.I/O Networking experience (i.e. Ethernet/IP, OPC, Profinet, and ModBus protocols) is advantageous.Basic networking experience.Experience in Data Analysis and Modeling (SQL, PI, Python) is advantageous.Commissioning and qualification, test protocol development and execution.Thorough knowledge of computer validation/SDLC requirements and automation change control procedures. (e.g., GAMP 5).We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:02/27/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.