Process Automation Systems Senior Engineer

An established engineering and manufacturing services organization is expanding its technical team across Central and Eastern North Carolina, supporting projects within highly regulated manufacturing environments. The business provides engineering, automation, integration, reliability, commissioning and qualification support to clients in industries including pharmaceutical and food manufacturing. We are seeking a Process Automation Engineer who can combine hands-on automation troubleshooting with commissioning, qualification, validation and change-control activities. This is a client-facing position supporting manufacturing equipment, utilities, facilities and process systems from initial implementation through routine production support. The successful candidate will work closely with Manufacturing, Engineering, Validation and Quality teams. Responsibilities will include troubleshooting existing systems, implementing automation modifications, supporting new equipment installations, developing technical and validation documentation, executing qualification activities and maintaining GMP compliance. Provide automation and maintenance troubleshooting support for new and existing manufacturing systems during qualification and routine production. Design, implement and support automation modifications, program changes and system enhancements. Support installation and implementation of new manufacturing equipment from design requirements through commissioning and qualification. Review equipment and process documentation to identify critical spare parts and support the development or improvement of preventive maintenance procedures. Work with client stakeholders to define system requirements and develop documents such as User Requirements, Design Specifications and Functional Specifications. Prepare lifecycle and validation documentation, including risk assessments, validation plans, equipment classification and alarm assessments. Develop and execute commissioning and qualification protocols, engineering studies and associated final reports or approval packages. Support deviation, failure and troubleshooting investigations and document findings. Initiate and manage change controls through the client's quality system. Provide project planning, coordination, execution and follow-up in collaboration with client teams. Create or support production documentation, including batch records, standard operating procedures and equipment-related documentation. Support continuous improvement initiatives relating to equipment reliability, automation performance and process functionality. Pharmaceutical / regulated manufacturing environments, with sterile manufacturing or medical-device experience beneficial. Allen-Bradley PLC platforms, particularly Studio 5000, FactoryTalk View and FactoryTalk Batch. Manufacturing equipment, process systems, utilities, facilities and computerized systems. Mechanical, electrical and P&ID drawings. Commissioning, qualification, validation and lifecycle documentation. Bachelor's degree in Engineering, Manufacturing Technology or a related technical discipline. ~3+ years of experience in pharmaceutical automation, validation or a closely related regulated manufacturing environment. ~ Strong mechanical aptitude with hands-on troubleshooting and problem-solving capability. ~ Practical experience supporting automation systems in a manufacturing environment. ~ Ability to work independently with limited supervision while also contributing effectively within multidisciplinary project teams. ~ CAPM or PMP certification is beneficial; Primarily Monday-Friday, day-shift work. Role is onsite at client facilities and/or the engineering office. Flexibility is required to support manufacturing schedules during equipment installations, commissioning, qualification and troubleshooting. Occasional night, weekend or on-call support may be required depending on project and production needs. H-1B sponsorship and H-1B transfers are not available for this position.