Senior Engineer I, Site Automation

Responsibilities

• Maintain and implement validated computing infrastructure and process automation systems for a 24x7 commercial manufacturing facility.
• Primarily support the Building Automation System and site Process Equipment.
• Lead the design, development, and qualification of automated processes, equipment, and systems.
• Manage technical documentation and support various control system hardware and software.
• Participate in controls fault analysis, remediation, and troubleshooting to resolve automation issues.
• Support the configuration, administration, and maintenance of manufacturing execution systems, data historians, and process control systems.
• Collaborate with global automation teams to ensure compliance with regulatory and site requirements.

Requirements

• Bachelor's degree in engineering or a related discipline.
• 5+ years of biopharmaceutical manufacturing, engineering, or project management experience.
• At least 3 years of project management experience specifically in biologics or GMP environments.
• 5+ years of experience in GMP pharmaceutical operations support.
• Strong experience with 21CFR Part 11 compliance and GxP computer systems validation (CSV).
• Proficiency with Rockwell PlantPAX DCS, Allen Bradley PLC, Rockwell FTView, FTAssetCentre, and MS-SQL.
• Proven ability to manage complex priorities and communicate effectively across functional teams.

Preferred Qualifications

• Master's degree in an engineering-related field.
• Experience with Siemens PLCs, WinCC, ABT Site, and OSI PI Historian.
• Experience with Ignition SCADA.
• Knowledge of GAMP computer systems validation practices.
• Experience with OE and/or LEAN Methodologies.

About the Company

BeOne Medicines is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a global team of over 11,000 colleagues, we are committed to radically improving access to medicines through bold ingenuity and a collaborative spirit.