Senior Pharmaceutical Automation Engineer
On-siteClayton, North Carolina, United States
Job Summary
Conduct automation engineering support for pharmaceutical manufacturing and packaging equipment throughout installation, commissioning, qualification, startup, and production support. Troubleshoot and resolve automation-related issues impacting manufacturing operations while coordinating activities with engineering, validation, manufacturing, quality assurance, vendors, and system integrators. Review, modify PLC, HMI, SCADA, MES, and industrial network configurations as required, and develop documentation including functional specifications, test protocols, SOPs, and system configuration records. Ensure systems comply with FDA 21 CFR Part 11, cGMP, GAMP 5, and data integrity requirements during FAT, SAT, IQ, OQ, and PQ activities. Support long-term reliability improvements and continuous process optimization for highly automated Fill Finish Expansion projects.
Required Qualifications
- Bachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Computer Engineering, or related technical discipline
- 5+ years of pharmaceutical or biotechnology automation engineering experience
- Experience supporting FDA-regulated manufacturing facilities
- Strong PLC troubleshooting experience with one or more major PLC platforms
- Experience supporting SCADA systems in pharmaceutical manufacturing
- Working knowledge of MES integration
- Experience supporting commissioning and qualification activities
- Understanding of ISA-88 and ISA-95 principles
- Familiarity with 21 CFR Part 11 and electronic records compliance
- Excellent troubleshooting and root cause analysis skills
- Strong communication and cross-functional collaboration abilities
- Ability to support commissioning, startup, off-shift troubleshooting, and occasional weekend activities during project milestones
- May require gowning and work within classified manufacturing areas
Desired Qualifications
- 8+ years of pharmaceutical automation engineering experience
- Experience supporting Fill Finish manufacturing facilities
- Experience with device assembly or high-speed packaging equipment
- Previous Novo Nordisk project experience
- Experience with PAS-X MES
- Experience with FactoryTalk SCADA architecture
- Knowledge of serialization systems
- Experience with AVEVA PI Historian
- Familiarity with ThinManager and Octoplant
- Experience supporting validated manufacturing environments
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