Merck
Rahway, NJ
Shift: Full time
Job Description The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge drug product cGMP clinical supply manufacturing facility, known as FLEx Non-Sterile. The FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization. The Specialist, Automation Engineering supports clinical manufacturing automation systems at the Rahway FLEx Center in Rahway, NJ, with a focus on non-sterile manufacturing operations. This role provides hands-on support for validated automation and OT/IT systems used in clinical and development manufacturing, including troubleshooting, system maintenance, change control, and documentation. The position works closely with Manufacturing, Quality, IT, and engineering partners to help ensure reliable, compliant operation of automation systems in a GMP environment. This is an onsite role that may require occasional off-shift or weekend support based on manufacturing needs. Primary Responsibilities Support automation systems used in clinical manufacturing by maintaining them in a validated, compliant state in accordance with cGMP, safety, data integrity, and cybersecurity requirements. Provide on-floor and technical support for manufacturing operations, including troubleshooting automation, controls, instrumentation, electrical, and software issues. Assist with root cause analysis, investigations, CAPAs, and corrective actions related to automation and OT/IT systems. Support system changes through change control, including documentation, impact assessments, implementation support, and testing. Assist with commissioning, qualification, and validation activities for new or modified automation systems and equipment. Maintain accurate and inspection-ready documentation, including SOPs, equipment records, drawings, configurations, and maintenance/support documents. Support automation-related reporting, trending, and basic visualization tools using historian or SCADA data to help monitor system performance and reliability. Work with divisional and enterprise IT, infrastructure, Quality, Manufacturing, and external vendors to support automation system reliability and compliance. Participate in audits, inspections, and site support activities as needed. Support automation lifecycle activities such as periodic reviews, backups, patching, user access administration, and obsolescence remediation under direction. Contribute to continuous improvement efforts focused on system stability, reliability, and supportability. Provide support for capital projects as a site automation representative, with limited scope focused on implementation support, testing, and system readiness. Education Requirement Bachelor’s degree in Engineering, Science, Information Technology, or a related field Minimum of 2 years of experience in process automation or a related technical area Required Experience and Skills Strong understanding of cGMP, quality systems, safety, data integrity, and validation principles for automation and computer systems Hands-on experience supporting validated automation systems in a regulated environment Experience with change control, troubleshooting, investigations, and documentation support Working knowledge of PLC/SCADA systems and industrial networking fundamentals Ability to troubleshoot across controls, instrumentation, electrical, software, and OT/IT layers Strong interpersonal, communication, and technical writing skills Demonstrated problem-solving skills and a continuous improvement mindset Ability to work collaboratively across functions and support multiple priorities in a fast-paced environment Preferred Experience and Skills Experience with Allen-Bradley and/or Siemens PLCs Experience with SCADA platforms such as iFix, WinCC OA, or Ignition Familiarity with industrial communication protocols such as OPC, Ethernet/IP, PROFINET, Profibus, DeviceNet, or AS-i Exposure to automation reporting, historians, databases, or basic scripting Experience in pharmaceutical manufacturing or other regulated manufacturing environments Experience supporting qualification or validation documentation Exposure to electronic quality or validation systems Experience supporting audits, SOPs, or controlled documentation #eligibleforERP FLEx2026 #PSCS Required Skills: Adaptability, Adaptability, Analytical Instrumentation, Automation Engineering, Automation Systems, Bioprocessing, Capital Projects, cGMP Compliance, Change Control Processes, Computerized Maintenance Management Systems (CMMS), Continuous Process Improvement, Data Analysis, Detail-Oriented, Electrical Systems, GMP Compliance, Information Communication Technology (ICT), Job Descri