Senior Manufacturing Systems Engineer – DeltaV Batch

• Lead technical projects, and drive innovation and support manufacturing’s upstream, downstream, and solution preparation automation needs
• Solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives
• Provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations
• Partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production
• Develop domain expertise to support operations upon start-up, focusing on manufacturing automation
• 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
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
• Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls
• Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units
• Provide mentoring to develop and accelerate site technical automation capabilities
• 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 Automaton systems, and Automation Systems 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
• Prepare and review Standard Operating Procedures (SOP) and cGMP documents

• High School Diploma / GED and 10 years of Engineering experience OR Associate’s 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
• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering
• 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
• Experience with upstream/downstream/solution prep unit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/diafiltration among others
• 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
• The ideal individual must be a 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

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering
• 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
• Experience with upstream/downstream/solution prep unit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/diafiltration among others
• 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
• The ideal individual must be a 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

competitive and comprehensive Total Rewards Plans