Senior Manufacturing Systems Engineer DeltaV Batch

Job Responsibilities

• Site design, construction, start-up, and operational readiness:
• 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 EmersonDeltaV 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.
• 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.
• 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
• Bachelors Degree and 4 years of Engineering experience OR
• Masters Degree and 2 years of Engineering experience OR
• Doctorate Degree

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
• Extensive experience with EmersonDeltaV, 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.