Manufacturing Systems Engineer – DeltaV (Swing Shift)
QvalFocus Inc. · Holly Springs, NC · Yesterday
On-siteEngineeringContract
Position Overview
Our client, a leading biopharmaceutical company, is seeking a Manufacturing Systems Engineer DeltaV to support manufacturing operations and capital projects at a GMP drug substance manufacturing facility. This role will focus on maintaining and optimizing Emerson DeltaV DCS automation systems, supporting manufacturing operations, troubleshooting process control issues, and participating in commissioning, qualification, and continuous improvement initiatives.
Key Responsibilities
- Configure, maintain, and troubleshoot Emerson DeltaV DCS automation systems supporting GMP manufacturing.
- Collaborate with Process Engineering, Manufacturing, and Quality teams to implement automation solutions.
- Support Factory Acceptance Testing (FAT), commissioning, qualification (IV/ACO), startup, and system integration activities.
- Investigate and resolve automation, instrumentation, and process control issues to ensure reliable plant operations.
- Execute and support Change Controls, CAPAs, Deviations, and Root Cause Investigations.
- Develop and maintain automation documentation, SOPs, engineering standards, and Data Integrity assessments.
- Drive continuous improvement initiatives to enhance system reliability, safety, and manufacturing efficiency.
- Provide day-to-day operational support, including participation in an on-call rotation.
Required Qualifications
- 2+ years of automation engineering experience in a GMP pharmaceutical or biotechnology manufacturing environment.
- Hands-on experience with Emerson DeltaV DCS configuration, troubleshooting, and lifecycle support.
- Experience supporting commissioning, qualification, startup, and manufacturing operations.
- Knowledge of GAMP 5, 21 CFR Part 11, ASTM E2500, ISA-88, ISA-95, and Computerized Systems Validation (CSV).
- Working knowledge of industrial communication protocols, including OPC, Foundation Fieldbus, and Profibus.
- Strong understanding of process automation, instrumentation, and regulated manufacturing environments.