We are seeking an experienced Siemens S7 Automation Engineer to support automation, controls, commissioning, qualification, and troubleshooting activities at a pharmaceutical/biotechnology manufacturing facility in Holly Springs, NC.
The ideal candidate will have strong hands-on experience with Siemens S7 PLC platforms, including programming, troubleshooting, system integration, and support of automated manufacturing equipment.
This role will work closely with Automation, Engineering, Manufacturing, Maintenance, Validation, and Quality teams to ensure reliable and compliant operation of automation and control systems in a GMP-regulated environment.
Key Responsibilities
- Design, configure, program, modify, and troubleshoot Siemens S7 PLC systems supporting pharmaceutical or biotech manufacturing operations.
- Provide hands-on expertise with Siemens S7-300, S7-400, S7-1200, and/or S7-1500 PLC platforms.
- Develop and modify PLC programs using Siemens TIA Portal and/or STEP 7.
- Support automation activities during equipment installation, commissioning, startup, and operational readiness.
- Troubleshoot complex PLC, HMI, instrumentation, controls, communication, and equipment-related issues.
- Configure and support Siemens HMI/SCADA systems, including WinCC, where applicable.
- Perform root cause analysis and implement corrective actions for automation and controls failures.
- Support integration between PLCs, field instruments, variable frequency drives, motor controls, skids, and manufacturing equipment.
- Work with cross-functional teams to improve equipment reliability, process performance, and overall manufacturing efficiency.
- Review automation and electrical drawings, including P&IDs, control narratives, functional specifications, loop diagrams, and wiring diagrams.
- Support FAT, SAT, commissioning, IQ, OQ, and PQ activities as required.
- Execute automation testing and document results in accordance with approved protocols and GMP requirements.
- Develop and review automation-related documentation, including URS, FRS, Functional Design Specifications, Software Design Specifications, test scripts, and traceability matrices.
- Ensure automation systems comply with applicable GMP, GAMP 5, 21 CFR Part 11, and data integrity requirements.
- Support change controls, deviations, CAPAs, investigations, and risk assessments related to automation systems.
- Participate in system startup, shutdown, recovery, and troubleshooting activities in a fast-paced manufacturing environment.
- Provide technical support to Manufacturing and Maintenance teams for automation-related issues.
- Identify opportunities for automation improvements, process optimization, and reliability enhancements.
- Support system upgrades, modifications, migration projects, and lifecycle management activities.
- Collaborate with equipment vendors, system integrators, and internal engineering teams during project execution.
- Ensure all work is completed in compliance with site safety, quality, engineering, and documentation requirements.
Required Qualifications
- Bachelor's degree in Engineering, Automation, Controls, Electrical Engineering, Computer Engineering, or a related technical discipline.
- 5+ years of hands-on automation and controls engineering experience.
- Strong hands-on experience with Siemens S7 PLC programming and troubleshooting.
- Experience with TIA Portal and/or STEP 7.
- Experience with one or more Siemens PLC platforms, including S7-300, S7-400, S7-1200, or S7-1500.
- Strong understanding of PLC architecture, control logic, industrial automation, and control system troubleshooting.
- Experience supporting automated manufacturing equipment and production systems.
- Knowledge of industrial communication protocols such as PROFINET, PROFIBUS, Ethernet/IP, Modbus, or OPC.
- Experience with HMI/SCADA systems, preferably Siemens WinCC.
- Ability to read and interpret electrical drawings, control schematics, P&IDs, and automation design documentation.
- Strong troubleshooting and root cause analysis skills.
- Excellent communication skills and ability to work effectively with cross-functional teams.
- Ability to work onsite in Holly Springs, NC.
Preferred Qualifications
- Experience in the Pharmaceutical, Biotechnology, Life Sciences, Medical Device, or other GMP-regulated industries.
- Experience supporting greenfield facilities, new facility startup, commissioning, or manufacturing expansion projects.
- Knowledge of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity requirements.
- Experience with automation system commissioning and qualification.
- Experience supporting process equipment, packaging equipment, utilities, or manufacturing skids.
- Familiarity with batch manufacturing and ISA-88 concepts.
- Experience with MES, SCADA, DCS, or historian systems.
- Experience supporting equipment vendors and system integrators during installation and startup.
- Strong understanding of change control, deviations, CAPA, and validation documentation.