Senior Manufacturing Systems Engineer DeltaV
Safety and On-Time Start-Up Support
Provide support to the capital project team with a strong focus on safety and on-time facility start-up. Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS) for upstream, downstream, and/or solution prep operations.
Commissioning and Qualification
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
Site Operations
Act as system owner for Upstream, Downstream, and/or Solution Prep Automation processes. Manage day-to-day operational support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automation systems, and Automation System spare parts management. Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as capital projects to integrate new drug substance manufacturing technologies into the facility. Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations. Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
Document Reviews and SOP Development
Prepare and review Standard Operating Procedures (SOP) and cGMP documents.
Qualifications
- High School Diploma / GED and 10 years of Engineering experience OR Associates Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree
- Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.
- Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
- Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.
- Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
- In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
- Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.
- Self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
- Strong leadership, technical writing, and communication/presentation skills.