Senior Engineer, Automation

What you'll do

• Maintain, configure, administer, and troubleshoot DeltaV, PI, and integrated process equipment.
• Serve as a subject matter expert for process automation systems and lead complex technical integrations.
• Initiate continuous improvement projects to enhance operational robustness and efficiency of automation systems.
• Provide 24/7 on-call troubleshooting and guidance support for manufacturing automation systems.
• Manage the automation system lifecycle to ensure compliance with quality requirements and manufacturing standards.
• Support critical business processes including audits, investigations, and Corrective and Preventive Actions (CAPA).
• Create and manage technical documentation such as P&IDs, network diagrams, and Standard Operating Procedures (SOPs).

What we're looking for

• Bachelor's degree in Engineering, Biological/Life Sciences, Chemistry, Biochemistry, or a related field.
• 5 years of relevant work experience or an equivalent combination of education and experience.
• 4+ years of experience with DeltaV, PI Historian, and OT Infrastructure.
• Expert understanding of S88, S95, and batch processing operations.
• Expert understanding of engineering documentation including P&IDs, network diagrams, process flow diagrams, and SOPs.
• Expert understanding of Validation Lifecycle Management, including the planning, creation, and execution of IQs, OQs, and PQs.
• Required experience with QMS systems (Veeva or similar) and GMP Quality Processes.
• Experience with IT Ticketing Systems (ServiceNow or similar).
• Knowledge of manufacturing processes, ERP, PCS, and MES (preferred).
• Working knowledge of Electronic Batch Records, Review by Exception, and MES Recipe object lifecycle management (preferred).
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques (preferred).
• Experience with manufacturing boundary systems (preferred).