Manufacturing Engineer (Upstream Process Automation SME)

Summary In this role, you will be driving both production excellence and digital transformation, this role combines hands-on Upstream GMP manufacturing with Automation SME leadership. You will partner with cross-functional teams to design and deploy MES and PCS (Delta V/Unicorn) solutions, ensuring a seamless transition from facility setup to live operations Department : Commercial Drug Substance (DS) Manufacturing Responsibilities : Represent Manufacturing team as key contact person to work with Automation, Engineering, Process Development and Validation teams to understand automation requirements and develop solutions. Responsible for the design, development, and implementation of automation systems for upstream manufacturing processes, including bioreactors, fermenters, and associated equipment. Lead the commissioning and qualification of automation systems. Provide technical expertise in the areas of process control systems (PCS), manufacturing execution systems (MES), and automation software. Develop and maintain automation documentation, including user requirements specifications, functional specifications, and standard operating procedures (SOPs). Troubleshoot and resolve automation-related issues, including hardware and software malfunctions. Collaborate with cross-functional teams to optimize upstream manufacturing processes and improve efficiency. Stay up-to-date with the latest automation technologies and industry best practices. Support continuous improvement initiatives within the manufacturing environment. Develop and deliver training to manufacturing personnel on automation systems and procedures. Key interfaces: Manufacturing, Automation, Engineering, Process Development, Validation, Quality, and external vendors. Requirements : Bachelor's degree in engineering, or a related field. 5+ years of experience in upstream manufacturing, with a focus on automation. Experience with Delta V and/or Unicorn systems is required. Strong understanding of GMP regulations and manufacturing processes. Excellent problem-solving and troubleshooting skills. Ability to work independently and as part of a team. Excellent communication and interpersonal skills. Experience with MES systems. Experience with PLC programming. Experience with SCADA systems. Experience with data analytics and process optimization. Experience with equipment automation and control. Experience in tech transfer activities. Benefits : Competitive salary Health insurance Paid time off Professional development opportunities Retirement plan